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TAG: IND

Sep 18, 2023

KayoThera, Inc. Nominates First-in-Class, Oral Inhibitor of the Retinoid Pathway in Genetically Defined Oncology Indications as a Development Candidate

Aug 25, 2023

AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment

Aug 16, 2023

Artiva Biotherapeutics Announces FDA Clearance of IND for AlloNK Cell Therapy Candidate in Combination with Rituximab in Lupus Nephritis

Aug 1, 2023

Amygdala Neurosciences Awarded $2.0 million NIH Grant to Conduct IND Enabling Studies

Aug 1, 2023

LEXEO Therapeutics Announces FDA Clearance of IND for LX2020, an AAV-based Gene Therapy Candidate for PKP2 Arrhythmogenic Cardiomyopathy

Jun 28, 2023

AusperBio Announces IND Approval from China CDE for HBV ASO AHB-137

Jun 17, 2023

IASO Bio Receives FDA Approval of IND Application for IASO-782 for Treatment of Autoimmune Disease

Jun 8, 2023

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791

May 25, 2023

Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells

May 17, 2023

Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer

Apr 19, 2023

Ankyra Therapeutics Presents Preliminary Canine Clinical Data with cANK-101 Supporting Therapeutic Potential of Anchored Immunotherapy

Apr 18, 2023

HUIDAGENE ANNOUNCES IND APPROVAL OF THE FIRST CHINA MULTI-REGIONAL, MULTI-NATIONAL MASTER PROTOCOL OF HG004 BY NMPA USA - English Deutschland - Deutsch France - Français

Apr 10, 2023

JW Therapeutics Announces IND Approval for the Clinical Trial of Relma-cel in Patients with Moderately or Severely Refractory Systemic Lupus Erythematosus USA - English APAC - English

Mar 15, 2023

ReCode Therapeutics Announces First Participants Dosed in a Phase 1 Healthy Volunteer Clinical Trial of Novel Disease-Modifying Genetic Medicine, RCT1100 for the Treatment of Primary Ciliary Dyskinesia

Mar 14, 2023

Sapience Therapeutics Receives IND Clearance from FDA to Proceed with Phase 1-2 Study of ST316 in Patients with Solid Tumors

Feb 28, 2023

Toragen, Inc. Announces FDA Acceptance of IND Application for TGN-S11 for the Treatment of HPV-Induced Cancers

Feb 23, 2023

Insilico Medicine Announces IND Approval of Oral 3CLpro Inhibitor ISM3312 for COVID-19

Feb 4, 2023

Egret Therapeutics Receives FDA Clearance of IND Application for EGT 101 for Treatment of Delayed Cerebral Ischemia

Feb 3, 2023

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0676 in B-cell Malignancies

Jan 30, 2023

Escient Pharmaceuticals Announces IND Clearance by FDA to Start Phase 1 Study of EP262, a First-in-Class Oral MRGPRX2 Antagonist for Mast Cell Mediated Disorders

Jan 27, 2023

HUIDAGENE THERAPEUTICS ANNOUNCES IND ACTIVE FOR THE MULTINATIONAL TRIAL OF HG004 TO TREAT INHERITED BLINDNESS USA - English France - Français Deutschland - Deutsch

Jan 26, 2023

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

Jan 6, 2023

HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200603

Jan 5, 2023

Azafaros Receives FDA's IND Clearance and Fast Track Designation for Lead Asset AZ-3102

Jan 3, 2023

Transcenta Received IND Clearance from NMPA for Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

Jan 3, 2023

HotSpot Therapeutics Announces FDA Clearance of IND Application for HST-1011, An Investigational Small Molecule Allosteric Inhibitor of CBL-B

Dec 22, 2022

Elpiscience Announces CDE IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors

Dec 19, 2022

Neurophth Receives IND Clearance from FDA for AAV-ND1 Gene Therapy of LHON

Dec 15, 2022

AnHeart Therapeutics Receives FDA Clearance of IND Application to Initiate Global Phase 2 Study of Safusidenib in Glioma

Dec 7, 2022

Sionna Therapeutics Announces IND Clearance and Phase 1 Initiation for SION-638 in Cystic Fibrosis

Dec 1, 2022

SparingVision’s lead asset SPVN06 clears IND application in the US for the treatment of retinitis pigmentosa

Nov 13, 2022

Nuance Pharma Announces Clearance of IND Application for Respiratory Syncytial Virus (RSV) Vaccine in China

Nov 10, 2022

Aulos Bioscience Presents Initial Data From First-in-Human Phase 1/2 Clinical Trial of Computationally Designed Antibody AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

Nov 10, 2022

Myeloid Therapeutics Presents Update On Myeloid Cell Programming Technologies, Including Non-Human Primate Proof-Of-Concept Data Delivering in vivo mRNA TROP-2 Targeting CAR (MT-302) at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

Nov 3, 2022

Eccogene Announces US IND Approval for GLP-1 Receptor Agonist ECC5004

Oct 31, 2022

Turnstone Biologics Announces FDA Clearance of IND for TIDAL-01, a Next-Generation TIL Therapy for Solid Tumors

Oct 25, 2022

Cellevolve Bio Receives FDA Clearance of IND Application and Orphan Drug Designation for CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)

Oct 19, 2022

Orionis Biosciences Secures $55 Million Financing to Support Advancement into Clinic

Oct 17, 2022

NKGen Biotech Receives IND Clearance from FDA for SNK02 Allogeneic Natural Killer Cell Therapy for Solid Tumors

Oct 14, 2022

Phanes Therapeutics announces FDA IND clearance for PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for patients with small cell lung cancer and other neuroendocrine cancers

Oct 4, 2022

Transcenta Received IND Clearance from FDA for Its Best-In-Class MASP2 Targeting Antibody TST004 for the Treatment of IgA Nephropathy

Sep 28, 2022

Azura Ophthalmics Provides Update on AZR-MD-001 Phase 2 Clinical Program Targeting Meibomian Gland Dysfunction

Sep 28, 2022

Code Biotherapeutics Names David Anderson, PhD, as Chief Scientific Officer

Sep 26, 2022

CatalYm Receives FDA IND Clearance to Expand Development of Visugromab in Advanced Cancer Patients into the U.S.

Sep 21, 2022

Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies

Sep 21, 2022

Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0803 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) USA - English USA - English USA - English

Sep 20, 2022

Artiva Biotherapeutics Announces FDA Allowance of IND for AB-201, a HER2-Targeted CAR-NK for the Treatment of Solid Tumors

Sep 20, 2022

Verismo Therapeutics Announces FDA Clearance of IND Application for SynKIR-110™, a KIR-CAR T Cell Immunotherapy Candidate

Sep 15, 2022

Inversago Pharma receives IND clearance for Phase 2 trial of INV-202 in Diabetic Kidney Disease

Sep 14, 2022

Transcenta Received IND Clearance from FDA for Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

Aug 29, 2022

Pharmazz Inc. announces Indian Central Drugs Standard Control Organization (CDSCO) Clearance of IND to conduct a Phase II clinical trial of sovateltide (PMZ-1620) in hypoxic-ischemic encephalopathy in neonates

Aug 24, 2022

Tachyon Receives IND Clearance from FDA to Develop Novel KDM4 Inhibitor TACH101 for Advanced Solid Tumors

Aug 19, 2022

World's First CAR-T for NMOSD Treatment, IASO Biotherapeutics' Equecabtagene Autoleucel, Receives IND Approval by NMPA

Aug 19, 2022

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-110, a KIR-CAR T-cell Immunotherapy Candidate

Aug 19, 2022

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0176 in Prostate Cancer

Aug 18, 2022

Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China

Aug 3, 2022

Lynk Pharmaceuticals Announces IND Approval of LNK01004 for Atopic Dermatitis in China

Aug 3, 2022

Avenge Bio Announces FDA Clearance of the AVB-001 IND for the Treatment of Ovarian Cancer, a Novel Cellular Therapy Leveraging the LOCOcyte™ Immunotherapy Platform

Aug 2, 2022

Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma

Aug 1, 2022

Eccogene Announces US IND Approval for THRβ agonist ECC4703

Jul 26, 2022

Sirnaomics Receives IND Clearance from the Taiwan Ministry of Health and Welfare for Phase I Clinical Study of RNAi Therapeutic STP705 for Liver Cancer Treatment

Jul 20, 2022

CAMP4 Secures $100 Million Series B Financing to Accelerate Expansion of its Novel Regulatory RNA-Targeting Platform and Advance Lead Programs into the Clinic

Jul 18, 2022

Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell™ Universal Donor Stem Cell for COVID-19 ARDS Outside of Ongoing Phase III Clinical Trial

Jun 27, 2022

US FDA Approves Prestige Biopharma’s IND for Phase 1/2a Trial of First-in-Class Pancreatic Cancer Treatment, PBP1510

Jun 20, 2022

Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy Candidate to Treat Patients with non-Hodgkin's Lymphoma

Jun 16, 2022

Global Cord Blood Corporation Announced Cellenkos Receives FDA Clearance of IND Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis

Jun 15, 2022

Phanes Therapeutics announces FDA IND clearance for PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction, and pancreatic cancers

Jun 14, 2022

Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis USA - English English English

Jun 7, 2022

EpimAb Biotherapeutics Announces U.S. FDA Clearance of IND Application for Phase Ib/II Trial of EMB-01 in Combination with Tagrisso for Non-Small Cell Lung Cancer

Jun 7, 2022

AUM Biosciences Announces FDA IND Authorization for Global Phase 2 Trial of Selection Translation Inhibitor AUM001 in Colorectal Cancer

Jun 1, 2022

FDA Grants AlgoTx IND Clearance for Phase 2 Trial of ATX01 in Chemotherapy-Induced Peripheral Neuropathy

May 28, 2022

IASO Biotherapeutics' Equecabtagene Autoleucel, the World's First CAR-T for Treatment of NMOSD, Receives IND Application Acceptance by NMPA

May 23, 2022

Xcovery SHP2 Inhibitor IND Approved by US FDA

May 23, 2022

Therapeutic Solutions International Receives IND Number 28508 for Chronic Obstructive Pulmonary Disease Clinical Trial and Enters Binding Discussions with FDA for Initiation of Phase I/II Clinical Trial

May 19, 2022

US FDA accepts Cytovation's IND application for Phase II combination studies of CyPep-1, a first-in-class targeted tumor membrane immunotherapy

May 17, 2022

Nouscom Announces Janssen Receives US FDA IND Clearance for VAC85135, an 'Off-The-Shelf' Cancer Immunotherapy Developed using Nouscom's Proprietary Viral Vector Platform

May 9, 2022

Elpiscience Announces FDA IND Clearance of ES014, a First-in-Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors

Apr 20, 2022

JW Therapeutics Announces IND Approval for the Clinical Trial of Carteyva in Pediatric and Young Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Apr 12, 2022

Osmol Therapeutics Announces Closing of Series A-1 Funding to Advance the Clinical Development of the First Therapy to Prevent Chemotherapy-Induced Neuropathy

Apr 8, 2022

Pyxis Oncology Announces Preclinical Data on Anti-Siglec-15 BSI-060T (PYX-106) Presented by Biosion, Inc. at the 2022 American Association for Cancer Research (AACR) Annual Meeting

Apr 4, 2022

Starton Therapeutics Announces FDA Clearance of IND Application for STAR-OLZ TDS for the Treatment of CINV

Apr 1, 2022

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer

Mar 31, 2022

JW Therapeutics Announces IND Approval for the Pivotal Clinical Trial of Carteyva in Second-line Large B-Cell Lymphoma

Mar 30, 2022

Receptor Life Sciences Announces FDA Acceptance of IND Application for RLS103 (Inhaled Dry Powder CBD) and Initiation of IND-Opening Clinical Safety and Efficacy Study

Mar 28, 2022

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1b/2a Study of PIPE-307 in Patients with Relapsing-Remitting Multiple Sclerosis

Mar 22, 2022

Phanes Therapeutics announces FDA IND clearance for PT199, a next generation monoclonal antibody against human CD73

Mar 21, 2022

Neuromagen Pharma Announces the Approval of a NIS 1.8M Budget from the Israel Innovation Authority RandD Fund Incentive Program USA - English USA - English

Mar 21, 2022

Neuromagen Pharma Announces the Approval of a NIS 1.8M Budget from the Israel Innovation Authority RandD Fund Incentive Program

Mar 17, 2022

Amolyt Pharma Announces US IND Clearance for the Ongoing Clinical Trial of AZP-3601 in Patients with Hypoparathyroidism

Mar 10, 2022

Pharmazz Inc. announces FDA clearance of an IND application for a Phase II clinical trial of centhaquine (PMZ-2010) in COVID-19 patients with ARDS

Mar 10, 2022

Scenic Biotech Announces $31 Million Financing to Progress Pipeline of Genetic Modifiers in Cancer and Rare Diseases

Mar 4, 2022

Aravax Pty Ltd announces opening of IND for Phase 2 clinical trials of PVX108, a next-generation immunotherapy for the treatment of peanut allergy

Mar 2, 2022

REDCLOUD BIO ANNOUNCES FDA ACCEPTANCE OF IND APPLICATION FOR NEXT-GENERATION EGFR INHIBITOR H002 IN NON-SMALL CELL LUNG CANCER

Feb 18, 2022

TransThera Announces that the IND Application of TT-01488, a Non-covalent Reversible BTK Inhibitor, for the Treatment of B-Cell Lymphomas has been Approved by the FDA in the US and Officially Accepted by the NMPA in China

Feb 15, 2022

AffaMed Therapeutics Announces IND Clearance by US FDA for AM712 - a Novel Bispecific Biologic for the Treatment of Retinal Vascular Diseases

Feb 15, 2022

Ranok Therapeutics to Present at BMO Biopharma Spotlight Series on Protein Degraders and Other Next Gen Technologies

Feb 9, 2022

Elpiscience Announces CDE Clearance of IND Application for Anti-CD39 Monoclonal Antibody ES002

Jan 31, 2022

Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors

Jan 31, 2022

Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker-Guided Global CNS Clinical Trial for Treatment-Resistant Depression (TRD)

Jan 25, 2022

Nanoscope Therapeutics Announces FDA Clearance of IND for MCO-010 Gene Therapy in Stargardt Macular Degeneration Patients

Jan 20, 2022

Palleon Pharmaceuticals Announces IND Clearance for First-in-Class Cancer Immunotherapy Leveraging Glyco-Immunology

Jan 20, 2022

AN2 Therapeutics Provides Regulatory Update and Plan to Initiate Clinical Development for Epetraborole Targeting NTM Lung Disease

Jan 19, 2022

Neurophth Therapeutics Receives IND Clearance to Initiate Clinical Trial for China AAV-ND4 Gene Therapy NR082 in Leber Hereditary Optic Neuropathy

Jan 9, 2022

Laekna Therapeutics and Innovent Biologics obtain IND approval for combination therapy in patients with specific types of solid tumors who have been refractory to treatment with PD-1/PD-L1 inhibitors

Jan 2, 2022

CStone Pharmaceuticals announced the IND approval of CS5001, a potential global best-in-class ROR1-targeting ADC by the U.S. Food and Drug Administration

Dec 24, 2021

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0176 in Prostate Cancer

Dec 12, 2021

Wugen Presents New Preclinical Data Supporting the Safety and Efficacy of WU-CART-007 for T-Cell Malignancies at the 63rd Annual Society of Hematology (ASH) Annual Meeting

Dec 9, 2021

K36 Therapeutics Launches with $30 Million Series A Financing from F-Prime Capital and Atlas Venture with Eight Roads Ventures

Dec 3, 2021

CAMP4 Presents In Vivo Data Supporting Novel Therapeutic Strategy for Dravet Syndrome at American Epilepsy Society Annual Meeting

Nov 17, 2021

OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of Attention Deficit Hyperactivity Disorder

Nov 12, 2021

Asher Bio Announces New Preclinical Data Demonstrating Best-in-Class Potential of AB248, Its Lead Cis-Targeted Il-2 Immunotherapy

Nov 8, 2021

ClearPoint Neuro Congratulates Neurona Therapeutics on IND Clearance for Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients

Nov 4, 2021

Acticor Biotech Announces FDA Acceptance of IND Application for glenzocimab in Acute Ischemic Stroke

Nov 4, 2021

Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients

Nov 4, 2021

PlateletBio Completes $75.5M Series B Financing

Nov 3, 2021

GRO Biosciences Announces $25M Series A Financing Led by Leaps by Bayer and Redmile Group

Nov 2, 2021

BioTheryX Receives IND Clearance from FDA to Proceed with Phase 1 Study of BTX-1188, a Molecular Glue, for the Treatment of Hematologic and Solid Malignancies

Oct 29, 2021

IMPACT Therapeutics Announced ATR Inhibitor IMP9064 IND Clearance by FDA

Oct 21, 2021

ATUM’s Leap-In Transposase Technology Supports Successful AskGene Pharma IND Clearance in China

Oct 13, 2021

Ambys Medicines Announces John Choi is Joining as VP of Regulatory Affairs as it Initiates IND Activities for its Lead Allogeneic Liver Cell Transplantation Program

Oct 4, 2021

Himalaya Therapeutics Announces Submission in Mainland China of IND Applications for its CAB-AXL-ADC to treat sarcomas and NSCLC, its CAB-ROR2-ADC to treat melanoma and NSCLC

Sep 29, 2021

US FDA approved IND submitted by Pharmazz, Inc. to initiate a phase III clinical trial of centhaquine in patients with hypovolemic shock

Sep 27, 2021

JW Therapeutics Announces IND Approval for the Clinical Trial of JWCAR129 USA - English USA - English USA - English España - español Deutschland - Deutsch France - Français

Sep 27, 2021

JW Therapeutics Announces IND Approval for the Clinical Trial of JWCAR129

Sep 26, 2021

Transcenta Received IND Clearance from NMPA of its Anti-sclerostin Monoclonal Antibody TST002

Sep 22, 2021

Model Medicines announces preclinical data in study of orally available lead therapeutic (MDL-001) against COVID-19, in partnership with Scripps Research and Mount Sinai, demonstrating efficacy against primary endpoint

Sep 21, 2021

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0682 in ER-Positive Breast Cancer

Sep 16, 2021

Bantam Pharmaceutical Completes $25 Million Seed Funding to Finalize Preclinical Development and Prepare for First in Humans Trials

Sep 13, 2021

Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors

Sep 13, 2021

Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors USA - English Brazil - Português

Sep 2, 2021

KAHR Announces FDA Clearance of IND Application for Phase 1b Trial of its Lead Anti-CD47 Candidate in Blood Cancers USA - English USA - English

Sep 2, 2021

KAHR Announces FDA Clearance of IND Application for Phase 1b Trial of its Lead Anti-CD47 Candidate in Blood Cancers

Sep 1, 2021

Innovative Cellular Therapeutics Receives FDA Clearance of IND Application to Initiate a Phase 1 Clinical Trial for GCC19CART, a CoupledCAR Platform Product Candidate for Relapsed or Refractory Metastatic Colorectal Cancer

Aug 26, 2021

Laekna Therapeutics Receives IND Approvals in China and US for Phase Ib/III Global Multi-center Clinical Study of Afuresertib in combination with fulvestrant for patients with HR+/HER2- breast cancer

Aug 25, 2021

Blade Therapeutics Announces FDA Activation of IND Application to Investigate Cudetaxestat, a Non-Competitive Autotaxin Inhibitor, in Idiopathic Pulmonary Fibrosis (IPF)

Aug 18, 2021

Treos Bio Announces FDA Clearance of IND Application for PolyPEPI1018 Immunotherapy for the Treatment of Metastatic Colorectal Cancer

Aug 18, 2021

Immunitas Therapeutics Completes $58 Million Series B Financing to Advance Pipeline into the Clinic and Expand Single Cell Analysis Drug Development Platform for Immuno-Oncology and Other Diseases

Aug 12, 2021

Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate First-In-Human Trial of IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Advanced Solid Tumors

Aug 9, 2021

YishengBio Announces PIKA recombinant COVID-19 vaccine received Phase I clinical trial IND clearance from New Zealand

Aug 4, 2021

Calidi Biotherapeutics Announces Agreement with Northwestern University for Exclusive Commercial Rights to their IND for Treatment of Malignant Glioma

Aug 2, 2021

IASO Biotherapeutics’ World’s First Fully Human CD19/CD22 Dual-Targeted CAR-T Drug Receives Two IND Clearances, Enters Clinical Trials

Jul 26, 2021

NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1 Study of NT-I7 (efineptakin alfa) for the Treatment of Kaposi Sarcoma in Patients With or Without HIV Infection

Jul 24, 2021

Allegro Ophthalmics Announces Positive Results of Vehicle-controlled Ex-U.S. Phase 2 Trial of ALG-1007 for the Treatment of Dry Eye Disease

Jul 19, 2021

YishengBio Announces PIKA recombinant COVID-19 vaccine received Phase I clinical trial IND clearance from the UAE USA - English USA - English

Jul 19, 2021

Elucida Oncology Submits IND Application for ELU-001 for the Treatment of Cancers Overexpressing Folate-Receptor Alpha

Jul 19, 2021

YishengBio Announces PIKA recombinant COVID-19 vaccine received Phase I clinical trial IND clearance from the UAE

Jul 7, 2021

ASC Therapeutics Receives IND Clearance From the U.S. Food and Drug Administration for ASC618 Second-Generation Gene Therapy for Hemophilia A

Jul 6, 2021

Sirnaomics Receives FDA Approval of IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 for Solid Tumor Treatment

Jul 6, 2021

Transcenta Announces NMPA Acceptance of IND Application of its Anti-Sclerostin Monoclonal Antibody TST002

Jun 23, 2021

Nanoscope Therapeutics Announces FDA Approval of IND for Phase 2b clinical trial of Optogenetic Gene Monotherapy to Restore Vision in Patients with Retinitis Pigmentosa

Jun 23, 2021

Revolo Biotherapeutics Announces US FDA Approval of IND Application for Phase 2 Trial of ‘1104 in Eosinophilic Esophagitis

Jun 23, 2021

Vita Therapeutics Raises $32 Million in Oversubscribed Series A Financing Led by Cambrian Biopharma to Advance the Development of Therapies to Treat Muscular Dystrophies

Jun 17, 2021

Xilio Therapeutics Announces FDA Acceptance of IND Application for XTX101 for the Treatment of Solid Tumors

Jun 15, 2021

CAMP4 Raises $45 Million to Usher in a New Era of Programmable Therapeutics to Upregulate Genes

Jun 2, 2021

Samsung Biologics and KAHR Medical Announce Development and Manufacturing Agreement for Cancer Immunotherapy Drug Candidate

May 20, 2021

IconOVir Bio Announces Preclinical Proof-of-Concept Data for Proprietary Mutations Designed to Improve Selectivity of Novel Oncolytic Viruses, Including Lead Product Candidate ICVB-1042

May 20, 2021

Xilio Therapeutics to Present Preclinical Data Highlighting Anti-Tumor Activity and Tolerability of XTX202 at the 2021 ASCO Annual Meeting

May 13, 2021

Osmol Therapeutics Initiates IND Enabling Studies to Develop First Therapy for Prevention of Chemotherapy-Induced Peripheral Neuropathy

May 12, 2021

Xilio Therapeutics Presents Preclinical Tumor-Selective Activity and Tolerability Data for XTX101 at Frontiers in Cancer Immunotherapy Virtual Symposium

May 11, 2021

Samus Therapeutics Receives IND Clearance from FDA for PU-AD for the Treatment of Recurrent Malignant Glioma

May 5, 2021

Genascence Announces Completion of Dosing and Interim Safety Data for Phase 1 Clinical Trial of GNSC-001 in Osteoarthritis

Apr 21, 2021

Apic Bio Announces FDA Clearance of IND Application for Lead Gene Therapy Candidate APB-102 for the Treatment of SOD1 ALS

Apr 20, 2021

Transcenta Received IND Clearance from US FDA for Initiating Phase I Clinical Trial for its Bi-functional Anti-PD-L1/TGF-β Antibody TST005

Apr 19, 2021

Istari Oncology Announces FDA Clearance of IND to Initiate LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy for PVSRIPO in Patients with Advanced Solid Tumors

Apr 12, 2021

Airway Therapeutics Announces FDA Acceptance of IND for AT-100's Second Indication in Severe COVID-19 Patients USA - English Deutschland - Deutsch Latin America - español España - español

Apr 12, 2021

Airway Therapeutics anuncia aceptación de la FDA de IND para AT-100 España - español Brazil - Português Latin America - español France - Français USA - English

Apr 12, 2021

Airway Therapeutics anuncia aceptación de la FDA de IND para AT-100 USA - English USA - Français India - English

Apr 12, 2021

Airway Therapeutics anuncia aceitação pela FDA de IND para a segunda indicação de AT-100 em pacientes de COVID-19 em estado grave Brazil - Português USA - Français India - English USA - Deutsch Latin America - español

Apr 12, 2021

Airway Therapeutics gibt die FDA-Zulassung für zweite Indikation von AT-100 als IND für COVID-19-Patienten mit schwerem Verlauf bekannt USA - Deutsch USA - Français Brazil - Português India - English Latin America - español

Apr 10, 2021

Synthekine Presents Data at AACR Annual Meeting 2021 Demonstrating Selective IL-2 Partial Agonist, STK-012, Promotes Anti-Tumor Response without Related Toxicities

Apr 6, 2021

MitoImmune Received FDA Clearance of IND Application for MIT-001, a Novel Anti-Inflammatory/Anti-Necrotic Therapy for Oral Mucositis in CCRT patients with Head and Neck Cancer

Apr 6, 2021

Arcellx Announces FDA Clearance of IND Application for ACLX-001, a Controllable Cell Therapy Utilizing the Company’s ARC-SparX Platform, for the Treatment of Multiple Myeloma

Apr 1, 2021

Neurophth Announces IND Approval by the NMPA for Leber Hereditary Optic Neuropathy Gene Therapy

Mar 31, 2021

Affimed and NKMax America Announce FDA Clearance of IND Application to Study the Combination of AFM24, an EGFR Targeted Innate Cell Engager, with SNK-01 Natural Killer Cell Therapy in Solid Tumors

Mar 26, 2021

Airway Therapeutics Announces FDA Acceptance of IND for AT-100 in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD) USA - English España - español USA - English

Mar 26, 2021

Airway Therapeutics anuncia la aceptación de la FDA de IND para AT-100 en bebés prematuros USA - English USA - English USA - English

Mar 26, 2021

Airway Therapeutics Announces FDA Acceptance of IND for AT-100 in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD) USA - English USA - español India - English

Mar 26, 2021

Airway Therapeutics anuncia aceitação pela FDA do IND para AT-100 em bebês prematuros em risco de displasia broncopulmonar (DBP) Brazil - Português USA - español USA - English Latin America - español India - English

Mar 26, 2021

Airway Therapeutics gibt die Genehmigung der FDA für die IND für AT 100 bei Frühgeborenen mit Risiko für bronchopulmonale Dysplasie (BPD) bekannt USA - Deutsch USA - español USA - English India - English

Mar 24, 2021

Enterome Receives FDA IND Clearance for EO2463, an 'OncoMimic' based Immunotherapy Targeting Liquid Tumors

Mar 16, 2021

Visus Therapeutics Announces FDA Acceptance of IND for Presbyopia-Correcting Eye Drop

Mar 16, 2021

Cytocom Receives FDA Clearance of IND for Phase 2 Clinical Trial of CYTO-205 as Treatment for COVID-19

Mar 10, 2021

Adaptive Phage Therapeutics Announces FDA Clearance of IND Application for PhageBank™ in Treatment of Diabetic Foot Osteomyelitis

Mar 9, 2021

Grifols reinforces its innovation strategy after completing the acquisition of GigaGen to boost a novel method to generate a wide range of immunoglobulins

Mar 3, 2021

eXIthera Pharmaceuticals Announces FDA Acceptance of IND Application for Phase 2 Trial of EP-7041 for Thrombosis Prevention in COVID-19 Patients

Mar 3, 2021

Dialectic Therapeutics Receives FDA Clearance of IND Application for Lead Antiapoptotic Protein Targeted Degradation (APTaD) Candidate DT2216

Feb 23, 2021

Elicio Therapeutics Announces FDA Clearance of IND application for ELI-002-- A Therapeutic Vaccine Targeting mutated KRAS Cancers

Feb 23, 2021

NeoImmuneTech Receives U.S. FDA IND Clearance for Pilot Study of NT-I7 (efineptakin alfa) in Progressive Multifocal Leukoencephalopathy

Feb 10, 2021

Adaptive Phage Therapeutics Announces FDA Clearance of IND Application for PhageBank™ for the Treatment of Prosthetic Joint Infections

Feb 4, 2021

Intrommune Receives IND Clearance From U.S. Food and Drug Administration for INT301

Jan 28, 2021

Cybrexa Therapeutics Reports Positive Results from GLP Toxicology Study of Lead Candidate CBX-12 (alphalex™-exatecan)

Jan 19, 2021

Gracell Biotechnologies Receives IND Approval from China NMPA for GC019F, a FasTCAR-Enabled CAR-T Therapy for the Treatment of Relapsed or Refractory Adult B-ALL

Jan 18, 2021

EdiGene Announces Approval of its IND Application for its CRISPR/Cas 9 Gene-editing Hematopoietic Stem Cell Therapy ET-01 in β-thalassemia by China National Medical Products Administration

Jan 7, 2021

UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

Jan 7, 2021

BlueRock Therapeutics in Collaboration with Memorial Sloan Kettering Cancer Center Receives IND Clearance for DA01 in Parkinson's Disease

Dec 23, 2020

EOM Pharmaceuticals Announces Its Pre-IND Meeting Request With U.S. FDA to Evaluate Plans for a Phase 2 Clinical Trial of Its Investigational Dual-Acting, Broad-Spectrum Immunomodulator in COVID-19 Patients

Dec 17, 2020

Brii Biosciences Provides Corporate Update on Progress Against Strategic RandD Priorities

Dec 15, 2020

Prometheus Biosciences Announces FDA Acceptance of IND Application for PRA023 and Commences Dosing in Phase 1a Clinical Study

Dec 14, 2020

Graphite Bio Receives IND Clearance to Initiate Clinical Trial for Next-Generation Gene Editing Therapy GPH101 in Sickle Cell Disease

Dec 7, 2020

Artiva Biotherapeutics Announces FDA Allowance of IND to Initiate Clinical Trials of AB-101 in Combination with Rituximab for the Treatment of Advanced B-cell Lymphomas

Dec 2, 2020

Exelixis In-Licenses Iconic Therapeutics’ Tissue Factor-Targeting Antibody-Drug Conjugate Ahead of Planned Investigational New Drug Application

Dec 1, 2020

LG Chem Life Sciences and TransThera Biosciences Announce FDA Clearance of IND for TT-01025, a SSAO/VAP-1 Inhibitor

Dec 1, 2020

Rhizen Pharmaceuticals Announces US FDA Acceptance of its IND Application for RP7214 in SARS-CoV-2 Infection; Phase 1 Clinical Trial of RP7214 Set to Begin Early December 2020

Nov 16, 2020

NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer

Nov 16, 2020

Istari Oncology Announces FDA Clearance of New IND to Open LUMINOS-102: PVSRIPO with and without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

Nov 2, 2020

enGene Announces FDA Clearance of IND Application for EG-70, an intravesical dual-immune modulator for the treatment of non-muscle invasive bladder cancer

Oct 29, 2020

Mebias Discovery Receives Grant from NIDA to Advance MEB-1170 as an Analgesic Drug Candidate for the Prevention and Treatment of Opioid Use Disorder

Oct 26, 2020

EdiGene Announces IND Application for its CRISPR/Cas 9 Gene-editing Hematopoietic Stem Cell Therapy ET-01 in β-thalassemia Accepted for Review by China National Medical Products Administration

Oct 7, 2020

OWP Pharmaceuticals Announces IND Approval for the First-Ever Liquid Oral Suspension Formulation of Quetiapine Fumarate for the Treatment of Schizophrenia and Bipolar Disorder

Sep 28, 2020

COVISTAT, a Subsidiary of Ensysce Biosciences Inc, a California Based Company With a Mission to Solve the Opioid Crisis, Is Commencing Phase 1 Study of Novel COVID-19 Treatment

Sep 24, 2020

Anokion Announces FDA Clearance of IND Application for ANK-700 for the Treatment of Multiple Sclerosis

Sep 21, 2020

Relief and NeuroRx Announce Partnership for Global Commercialization of RLF-100 and Selection of Commercial Partners

Sep 21, 2020

Relief and NeuroRx Announce Partnership for Global Commercialization of RLF-100™ and Selection of Commercial Partners

Sep 15, 2020

EpimAb Biotherapeutics Announces FDA Clearance of its IND Application for EMB-02, a Bispecific Dual Checkpoint Inhibitor

Sep 14, 2020

Seneca Therapeutics, Inc. Receives Positive Feedback from FDA on Reactivation of the SVV-001 IND and Phase I/II Protocol

Sep 8, 2020

Caribou Biosciences Announces FDA Clearance of its IND for CB-010, an Off-the-shelf Allogeneic Anti-CD19 CAR-T Cell Therapy

Sep 2, 2020

AEON Biopharma Announces FDA Acceptance of IND for ABP-450 as a Treatment for Cervical Dystonia; Secures $25 Million Investment

Aug 26, 2020

HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients

Aug 24, 2020

NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1b Study of NT-I7 (efineptakin alfa) and Kymriah (tisagenlecleucel) in Relapsed/Refractory Large B-Cell Lymphoma

Aug 20, 2020

CARsgen Therapeutics Receives IND Clearance from the NMPA for CT041 CLDN18.2-CAR-T Cells

Aug 20, 2020

Cytocom, Inc. Announces Agreement to Reacquire Rights to Lead Drug Candidate CYTO-201 and CYTO-401 in Emerging Markets

Aug 12, 2020

KAHR Medical Announces FDA Clearance of IND Application for DSP107, anti-CD47 Candidate for the Treatment of Solid Tumors USA - English USA - English

Aug 12, 2020

KAHR Medical Announces FDA Clearance of IND Application for DSP107, anti-CD47 Candidate for the Treatment of Solid Tumors

Aug 3, 2020

Cybrexa Therapeutics Expands Scientific Advisory Board With Appointment of Leader in Lung Cancer Research Roy Herbst, M.D., Ph.D.

Jul 30, 2020

Sound Pharmaceuticals files IND to test SPI-1005 in Phase 2 COVID-19 trials

Jul 27, 2020

CARISMA Therapeutics Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy

Jul 27, 2020

NeoImmuneTech Announces Receipt of IND Clearance to Conduct Window-of-Opportunity Trial of NT-I7 (efineptakin alfa) in Patients with Locally Recurrent Squamous Cell Carcinoma of Head and Neck

Jul 20, 2020

NeoImmuneTech Receives U.S. FDA Clearance of IND Application for Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo (nivolumab)

Jul 9, 2020

Kronos Bio Reports Positive Results of Preclinical Study of KB-0742, an Investigational CDK9 Inhibitor, Demonstrating Potency, Selectivity and Anti-tumor Activity in Prostate Cancer Model

Jul 8, 2020

FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma

Jul 7, 2020

Cybrexa Therapeutics Completes Successful Pre-IND Meeting With FDA for CBX-12 (alphalex™-exatecan), a Novel Treatment for Solid Tumors

Jun 24, 2020

HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia

Jun 22, 2020

Shasqi Demonstrates Chemistry-based Platform Produces Local and Systemic Anti-tumor Response in Preclinical Cancer Model

Jun 9, 2020

NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac in Lung Cancer

Jun 9, 2020

Bacainn Therapeutics Announces IND Clearance for BT051 and Initiation of Phase 1 Clinical Trial, Bacainn’s First Clinical Candidate for the Treatment of Ulcerative Colitis

Jun 4, 2020

FDA Approves Elixirgen Therapeutics IND Application for Therapy for Telomere Biology Disorders with Bone Marrow Failure

Jun 2, 2020

NKMax America Receives FDA Clearance of IND for Phase I/2a Trial of their Natural Killer Cell Therapy (SNK01) in Combination with Trastuzumab or Cetuximab for the Treatment of Advanced/Metastatic HER2- or EGFR- Expressing Cancers

Jun 2, 2020

Treadwell Therapeutics Announces US FDA Clearance of IND Application for Phase 1/2 Study of HPK1 Inhibitor, CFI-402411

Jun 1, 2020

Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy

May 29, 2020

Immune-Onc Therapeutics IND Application for First-In-Human Trial of IO-202, a Novel Antibody for the Treatment of Acute Myeloid Leukemia, Receives FDA Clearance

May 28, 2020

Bird Rock Bio Files IND Application for Phase 2 Study of Nimacimab for Treatment of Renal Diseases

May 27, 2020

Azitra Announces Rare Pediatric Disease Designation for ATR-12 for the Treatment of Netherton Syndrome

May 20, 2020

Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing

May 18, 2020

CARsgen Therapeutics Receives IND Clearance from the US FDA for CT041 CLDN18.2-CAR-T Cells

May 15, 2020

Leading BioSciences Receives IND Clearance for Phase 2 COVID-19 Study

May 8, 2020

HJB and Mabspace Biosciences' Development and Manufacturing Agreement for Novel Humanized Claudin18.2 Monoclonal Antibody Accomplished FDA and NMPA IND Clearance

Apr 28, 2020

F-star Therapeutics Announces Positive Preclinical Antitumor Activity and Safety of FS222 Published in Clinical Cancer Research

Apr 22, 2020

Samsung Biologics and ImmuneOncia Therapeutics Inc. Development and Manufacturing Agreement Accomplishes IND Clearance of IMC-002 (anti-CD47 antibody)

Apr 20, 2020

Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Humanized Claudin 18.2 Monoclonal Antibody TST001

Apr 15, 2020

Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Immune Thrombocytopenia

Apr 14, 2020

Grid Therapeutics Announces FDA Approval of IND Application for GT103

Mar 26, 2020

RELIEF THERAPEUTICS and NeuroRx, Inc. File FDA IND for Aviptadil to Treat COVID-19-induced Respiratory Distress English English English

Mar 26, 2020

RELIEF THERAPEUTICS and NeuroRx, Inc. File FDA IND for Aviptadil to Treat COVID-19-induced Respiratory Distress USA - English Israel - English

Mar 10, 2020

Cadent Therapeutics Announces FDA Clearance of IND Application and Dosing of Subjects of CAD-9303 for Schizophrenia

Mar 3, 2020

EpicentRx IND Application for Second Immuno-oncology Program, a TGF-β Trap Adenovirus, Receives FDA Clearance

Feb 28, 2020

Harbour BioMed Announces U.S. FDA Approval of IND for Its Next Generation anti-CTLA-4 Antibody, HBM4003, to Treat Cancer

Feb 27, 2020

Harbour BioMed Receives U.S. FDA IND Approval for Phase 2 Clinical Trial and Orphan Drug Designation for Anti-PD-L1 Monoclonal Antibody, HBM9167

Feb 11, 2020

Lyndra Therapeutics Files IND, Bolsters Leadership Team and Readies for Manufacturing

Feb 6, 2020

Kleo Pharmaceuticals Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic

Jan 30, 2020

F-star Therapeutics Announces FDA Acceptance of IND Application for FS120

Jan 27, 2020

NeoImmuneTech Received U.S. FDA Clearance of IND Application for Phase 1b/2a Study of Hyleukin-7™ (NT-I7) and KEYTRUDA (Pembrolizumab) in Relapsed/Refractory Advanced Solid Tumors

Jan 23, 2020

Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)

Jan 22, 2020

Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

Jan 21, 2020

Anokion Announces FDA Clearance of IND Application for its Lead Program in Celiac Disease

Jan 20, 2020

Transcenta Announces Acceptance by NMPA of IND Application of a Novel Humanized Claudin 18.2 Monoclonal Antibody

Jan 10, 2020

Indapta Therapeutics and Lonza Announce Strategic Partnership to Advance a Next-generation, Off-the-shelf, Allogeneic Immuno-oncology Therapy

Jan 1, 2020

WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392

Dec 30, 2019

OncoImmune Announces Approval of IND Application for ONC-392 – The anti-CTLA-4 Antibody that Preserves CTLA-4 Recycling for Better Safety and Efficacy

Dec 19, 2019

NexImmune Receives IND Clearance for Phase 1/2 Trial in Relapsed / Refractory Multiple Myeloma

Dec 18, 2019

Zentalis Pharmaceuticals Announces FDA Clearance of the IND for Its Third Oncology Drug Candidate, ZN-c3, a WEE1 Inhibitor, and the Dosing of the First Patient in a Phase 1/2 Clinical Trial

Dec 16, 2019

TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure

Dec 9, 2019

CARsgen Therapeutics Receives IND Clearance from the NMPA for AB011 Humanized Claudin18.2 Monoclonal Antibody

Dec 5, 2019

Meissa Vaccines Receives FDA Clearance of IND Application for a Phase 1 Clinical Trial of MV-012-968 for Respiratory Syncytial Virus

Dec 4, 2019

Bio-Thera Solutions Announces NMPA approval of IND Application to Initiate Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara (Ustekinumab)

Dec 4, 2019

Innovative Cellular Therapeutics Announces FDA Clearance of IND for its Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

Dec 3, 2019

OWP Pharmaceuticals Announces a Second IND Approval and Patent Application: The First-Ever Liquid Oral Suspension Formulation of Lamotrigine for the Treatment of Epilepsy and Bipolar Disorder

Dec 3, 2019

Kyn Therapeutics Rebrands as Ikena Oncology, Reflecting Next Phase of Growth

Nov 20, 2019

OWP Pharmaceuticals Announces IND Approval and Patent Application for the First-Ever Liquid Oral Suspension Formulation of Topiramate for the Treatment of Epilepsy and Migraine

Nov 14, 2019

I-Mab Biopharma Receives IND Approval from NMPA to Initiate Clinical Trials for its Anti-GM-CSF Monoclonal Antibody TJM2 in China

Nov 6, 2019

American Gene Technologies Hosts Celebration Event For Its First IND Submission (For HIV) To The Food and Drug Administration (FDA)

Oct 31, 2019

NexImmune Receives IND Clearance for Phase 1/2 Trial in Acute Myeloid Leukemia / Myelodysplastic Syndrome

Oct 30, 2019

AffyImmune Therapeutics Announces IND Approval for a First-in-Man Trial of Affinity-Tuned CAR-T cells for Patients with Advanced, Refractory Thyroid Cancer

Oct 18, 2019

IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies

Oct 14, 2019

I-Mab Biopharma and MorphoSys Announce IND Clearance to Initiate Clinical Trials of TJ202/MOR202 for the Treatment of Multiple Myeloma in Mainland China

Oct 10, 2019

EicOsis Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain

Oct 4, 2019

I-Mab Biopharma Receives IND Approval in China for Proprietary CD73 Antibody TJD5

Oct 2, 2019

NMPA Approves IND Application for CT103A, a Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by IASO BIO and Innovent Biologics

Oct 1, 2019

Immunomic Therapeutics Assumes Sponsorship of ATTAC-II IND for ITI-1000, a Dendritic Cell Vaccine in Phase 2 for the Treatment of GBM

Jul 23, 2019

Immix Receives FDA Authorization to Expand Clinical Trial under US IND

Jul 23, 2019

Samus Therapeutics Launches PU-AD Clinical Program in Alzheimer's Disease

Jun 26, 2019

Yisheng Biopharma Receives IND Clearance from China NMPA to Initiate Clinical Trial of YS-ON-001 in the Treatment of Advanced Solid Tumors

Jun 19, 2019

CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA

Jun 19, 2019

ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury

Jun 18, 2019

Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19

Jun 4, 2019

Prevail Therapeutics Announces IND Active for Phase 1/2 Trial of its Gene Therapy PR001 to Treat Parkinson’s Disease Patients with GBA1 Mutations

Jun 3, 2019

Nouscom - IND for NOUS-209, an 'off-the-shelf' Neoantigen Cancer Vaccine, Cleared by FDA to Commence Clinical Development in MSI Solid Tumors

May 29, 2019

BioTheryX Announces FDA approval of IND Application to Initiate Phase I Clinical Trial in Relapsed or Refractory Acute Myeloid Leukemia

May 7, 2019

Neuronascent Announces FDA Clearance of IND Application for NNI-362 an Aging Therapy to Treat Alzheimer's Disease

Mar 26, 2019

Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study

Mar 8, 2019

Cerebral Therapeutics Raises Series A Extension Financing to Advance Clinical-Stage Drug Device Combination Therapy to Phase 3 Readiness for Adult Refractory Epilepsy

Mar 5, 2019

NKMax America Announces FDA Approval of IND for Phase 1 Trial of SNK01 in Patients with Refractory Cancer

Mar 1, 2019

CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the NMPA

Feb 20, 2019

Koutif Therapeutics Announces FDA Acceptance of IND Application for Novel New Treatment of IBD

Feb 7, 2019

CStone and IMPACT Therapeutics' clinical collaboration progresses to IND filing acceptance for CS1001+IMP4297 combination therapy

Jan 30, 2019

Eureka Therapeutics Announces US FDA Clearance of IND Application for Phase 1/2 Trial of ET140202 Artemis T-Cell Therapy, for the Treatment of Liver Cancer

Jan 29, 2019

CARsgen Therapeutics Receives IND Clearance for GPC3-CAR-T Cells from the NMPA

Jan 16, 2019

AIVITA Biomedical Receives IND Clearance for Phase 1B Melanoma Trial

Jan 16, 2019

NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers

Dec 27, 2018

Bio-Thera Solutions Files IND for Phase 1 Clinical Trial with BAT8003 (Trop2-ADC) as Treatment for Trop2 Positive Cancers

Dec 10, 2018

Sermonix Announces FDA Acceptance of IND Application; Will Begin Phase 2 Trial of Lasofoxifene for Targeted Treatment of Women With ESR1 Mutations in Metastatic Breast Cancer

Dec 7, 2018

XenoTherapeutics to Start First Human Trial of Xeno-Skin™, a Novel Xenotransplantation Treatment for Severe Burns

Nov 7, 2018

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease

Nov 6, 2018

Fortis Therapeutics Receives FDA Clearance of Two IND Applications for Novel Anti-CD46 Therapeutic for Treatment of Late-Stage Prostate Cancer and Multiple Myeloma

Nov 1, 2018

Adagene Announces First Patient Dosed in United States and Acceptance of IND in China for ADG-106

Oct 23, 2018

CANbridge Pharmaceutical and WuXi Biologics Enter into Strategic Partnership for Rare Disease Therapeutics

Oct 22, 2018

Cybrexa Therapeutics Expands Scientific Advisory Board Ahead of IND Filing

Oct 2, 2018

PharmAbcine Announces FDA Accepts IND Application of TTAC-0001 for the Treatment of Recurrent Glioblastoma

Sep 28, 2018

TransThera Biosciences Granted IND Approval from FDA to Soon Start Clinical Trials Targeting TNBC

Sep 13, 2018

EpimAb Biotherapeutics Announces IND Filing for EMB01 in China and the US

Sep 5, 2018

Advicenne Announces FDA Clearance of IND to Commence Pivotal Phase 3 Trial of ADV7103 for Distal Renal Tubular Acidosis

Sep 5, 2018

MabSpace Biosciences Doses First Patient in China Phase 1 Trial for MSB2311 and Submitted IND for MSB0254 to NMPA

Aug 16, 2018

Sirnaomics Oncology IND Receives Green Light from US FDA to Initiate Study for Treatment of Cholangiocarcinoma

Jul 20, 2018

Koutif Therapeutics Confirms Clinical Candidate Drug

Jul 19, 2018

SiteOne Therapeutics to Present Research Findings for Selective Small Molecule Nav1.7 Inhibitors at the 2018 World Congress on Pain

Jul 17, 2018

RDD Pharma Announces IND Clearance to Advance RDD-0315 to Treat Fecal Incontinence in Patients with Spinal Cord Injury

Jul 10, 2018

US FDA Approves Adagene IO Agonist IND for Solid Tumor and Non-Hodgkin Lymphoma Ph1 Trial

Jun 27, 2018

Oyster Point Pharma Announces FDA Clearance of Investigational New Drug Application for the Treatment of Dry Eye Disease

Jun 22, 2018

Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine

Jun 20, 2018

AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial

Jun 19, 2018

ITM: FDA Acceptance of IND to Advance Phase III Clinical Trial COMPETE with Solucin for Treatment of GEP-NET in the U.S.

May 16, 2018

Turnstone Biologics Announces U.S. FDA Acceptance of IND for Immunotherapy Targeting HPV Positive Cancers

May 8, 2018

Palladio Biosciences Receives FDA IND Clearance to Begin the ELISA Study, a Phase 2 Clinical Trial with Lixivaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Apr 17, 2018

Antimicrobial Innovator Amicrobe, Inc. Positions Management Team In Anticipation Of Product Trials

Apr 11, 2018

Evotec Forms Collaboration with Petra Pharma on Indigo Platform

Mar 15, 2018

Tetra Discovery Partners Announces FDA Clearance of IND for Phase 2 Trial of BPN14770 in Fragile X Syndrome

Feb 22, 2018

MabSpace Biosciences Announces FDA Approval of IND for MSB2311, a Second Generation PD-L1 Antibody With pH Dependent Antigen Binding and Recycling Property

Feb 16, 2018

Avillion Advances Co-development Programme with Merck: IND Now Open for Phase 2 Study of M1095, an Anti-IL-17 A/F Nanobody in Psoriasis

Feb 1, 2018

Imago BioSciences Receives FDA Approval of IND Application for the Treatment of Myeloid Malignancies

Jan 24, 2018

Treos Bio Announces FDA Approval of IND of Its First PolyPEPI™ Precision Cancer Vaccine for Metastatic Colorectal Cancer

Jan 8, 2018

Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection

Jan 3, 2018

Asana BioSciences Announces Acceptance of IND Application for Its Oral ERK1/2 Inhibitor

Nov 15, 2017

Ascentage Pharma Announces U.S. FDA Acceptance of IND Application for Clinical Study of Novel IAP Inhibitor APG-1387 to Treat Advanced Solid Tumors and Blood Cancers

Oct 11, 2017

CicloMed Announces FDA Clearance of IND Application for Ciclopirox Prodrug in the Treatment of Bladder Cancer

Oct 3, 2017

DiscGenics Receives FDA Allowance of IND to Commence Clinical Study of Its Degenerative Disc Disease Therapy

Sep 26, 2017

Spiral Therapeutics Receives Positive IND Submission Guidance from FDA

Sep 19, 2017

4D Molecular Therapeutics Receives $3 Million Follow-On Funding from Cystic Fibrosis Foundation Therapeutics for Gene Therapy IND Candidate for Cystic Fibrosis

Jul 12, 2017

Meissa Vaccines awarded $1.6m Fast Track SBIR Grant to advance IND preparations for RSV vaccine candidate

May 30, 2017

Intensity Therapeutics, Inc. Successfully Administers INT230-6 to First Patient in a Phase 1/2 Trial

May 22, 2017

ViaCyte Receives IND Allowance from FDA and Clearance from Health Canada to Commence International Clinical Trial of PEC-Direct Cell Therapy for High-Risk Type 1 Diabetes

May 11, 2017

BioAxone BioSciences Announces New Hires to Support Investigational New Drug Filing

May 1, 2017

Sirnaomics Received IND Approval from CFDA for Its Leading siRNA Therapeutic Candidate, STP705, for Treatment of Hypertrophic Scar

Apr 28, 2017

Medeor Therapeutics Receives FDA Clearance of IND Application and Special Protocol Assessment for Pivotal Clinical Study of MDR-101

Mar 16, 2017

Asana BioSciences Announces FDA Acceptance of the IND Application for its Novel SYK-JAK Inhibitor for Evaluation in Atopic Dermatitis

Feb 1, 2017

Hope Biosciences Acquires Worldwide Rights To Novel MERTK/AXL Inhibitor From NeoPharm

Jan 4, 2017

NeuroRx announces FDA IND clearance for NRX-101 phase 2b/3 study and publication of promising biomarker data

Oct 18, 2016

CStone Pharmaceuticals' PD-L1 monoclonal antibody IND has been formally accepted by the CFDA

Oct 5, 2016

Velicept Therapeutics Announces FDA Acceptance of IND Application of Novel, Once-Daily Formulation of Solabegron for the Treatment of Overactive Bladder

Oct 4, 2016

Asana BioSciences Announces Acceptance of Its Third IND Application in Oncology

Aug 17, 2016

Ambrx's Innovative Antibody Drug Conjugate (ADC) US IND Active

Sep 16, 2015

EnGeneIC Ltd. to Initiate U.S. Phase 1 Clinical Study Using Targeted EDV™ Nanocells to Treat Advanced Glioma Patients

Jun 22, 2015

T3D Therapeutics, Inc. Receives FDA IND Approval to Begin Phase 2 Clinical Study of T3D-959 in Alzheimer's Patients

Jun 9, 2015

Goodwin Biotechnology and Aspyrian Therapeutics Collaborate on the Successful GMP Manufacturing and IND Submission for a Novel Antibody Drug Conjugate (ADC) Platform

Apr 8, 2015

ArmaGen Announces FDA Acceptance of IND Application for AGT-181 for the Treatment of Hurler Syndrome

Mar 16, 2015

ADC Therapeutics Submits its First IND For a Novel Antibody Drug Conjugate Against Lymphomas

Feb 2, 2015

Leading BioSciences Recieves FDA IND Clearance To Proceed With A Randomized, Multi-Center Phase 2 Clinical Trial Using LB1148 To Treat Septic Shock

Jan 13, 2015

Batu Biologics Appoints Biopharmaceutical Executive Dr. Alan Lewis as Chairman of the Board

Jan 12, 2015

Milestone Pharmaceuticals Receives FDA Clearance of MSP-2017 Phase 2 IND

Jan 5, 2015

Sirnaomics and Partner Submit IND to CFDA for Its First Anti-fibrosis siRNA Therapeutic

Dec 11, 2014

ArmaGen Announces FDA Acceptance of IND Application for AGT-182 for the Treatment of Hunter Syndrome

Nov 6, 2014

Leading BioSciences Submits Expanded Access, Compassionate Use IND For LB1148 To Treat Ebola-Related Shock And Multi-Organ Failure

Aug 19, 2014

ViaCyte, Inc. Announces FDA Acceptance of IND to Commence Clinical Trial of VC-01™ Candidate Cell Replacement Therapy for Type 1 Diabetes

May 23, 2014

AZTherapies cleared to start enrolling under their IND for a Phase III clinical efficacy study for ALZT-OP1 in early Alzheimer's disease

Dec 17, 2013

CMC Biologics and OncoSynergy Enter into Agreement to Develop and Manufacture Material for IND Enabling Studies and Phase I Clinical Trials

Jul 29, 2013

Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering Microbiota Restoration Therapy

Aug 15, 2012

Apexigen Announces the Filing of an IND by its Partner, 3SBio

May 3, 2012

Immunomic Therapeutics Receives IND Authorization for Phase I Study of JRC-LAMP-Vax Vaccine to Treat Japanese Red Cedar (Sugi) Allergy

Feb 6, 2012

Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel Intranasal Diazepam Formulation

Mar 11, 2011

Apexigen Announces the Filing by its Partner, Simcere Pharmaceutical Group, of First IND

Jul 15, 2010

Nitto Denko and Quark Pharmaceuticals to Enter Into Collaboration to Develop a Novel siRNA Anti-fibrotic Drug

Nov 17, 2008

APR Applied Pharma Research and Fidia Farmaceutici Receive IND Approval from FDA for a New NSAID Matrix Patch Product