Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals
Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals Amneal Pharma, a global leader in pharmaceuticals, today announced the progression of two significant strat ...
BridgeBio Pharma’s Attruby™ Approved by FDA for Treating Transthyretin Amyloid Cardiomyopathy
BridgeBio Pharma's Attruby™ Approved by FDA for Treating Transthyretin Amyloid Cardiomyopathy BridgeBio Pharma, Inc., a biopharmaceutical company pioneering treatments for genetic diseases, today anno ...
Ractigen Therapeutics’ RAG-21 Receives FDA Orphan Drug Designation for Treating FUS-ALS
Ractigen Therapeutics' RAG-21 Receives FDA Orphan Drug Designation for Treating FUS-ALS Ractigen Therapeutics, a clinical-stage pharmaceutical company dedicated to developing innovative therapies, tod ...
Vaderis Therapeutics’ VAD044 Receives FDA Fast Track Designation for Treating Hereditary Hemorrhagic Telangiectasia
Vaderis Therapeutics' VAD044 Receives FDA Fast Track Designation for Treating Hereditary Hemorrhagic Telangiectasia Vaderis Therapeutics AG, a clinical-stage biotechnology company focusing on treatmen ...
Vir Biotechnology Secures EMA Orphan Drug Designation for Tobevibart and Elebsiran in Treating Chronic Hepatitis Delta
Vir Biotechnology Secures EMA Orphan Drug Designation for Tobevibart and Elebsiran in Treating Chronic Hepatitis Delta Vir Biotechnology, Inc. has announced a significant milestone in the fight agains ...
FDA Accepts Unicycive’s NDA for Oxylanthanum Carbonate, PDUFA Date June 2025
FDA Accepts Unicycive’s NDA for Oxylanthanum Carbonate, PDUFA Date June 2025 Unicycive Therapeutics, Inc., a clinical-stage biotechnology company developing therapies for patients with kidney disease, ...
FDA Extends PDUFA Date for Neurotech’s NT-501 Eye Cell Therapy Implant
FDA Extends PDUFA Date for Neurotech’s NT-501 Eye Cell Therapy Implant Neurotech Pharmaceuticals' eye cell therapy implant has faced a delay, as the US Food and Drug Administration (FDA) extended the ...
FDA Clears CytoDyn’s Leronlimab for Phase II Trial in Colorectal Cancer
FDA Clears CytoDyn’s Leronlimab for Phase II Trial in Colorectal Cancer CytoDyn Inc., a biotechnology company specializing in the development of leronlimab, a CCR5 antagonist with potential for multip ...
US FDA Clears HuidaGene’s HG202 IND Application for Innovative RNA-Editing Therapy for Neovascular AMD
HuidaGene Therapeutics (HuidaGene), a global clinical-stage biotechnology company specializing in genome medicines, has announced that the US FDA has cleared its HG202 investigational new drug (IND) a ...
FDA Fast Tracks FELIQS’ FLQ-101 for Preventing Retinopathy of Prematurity (ROP)
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to FELIQS' lead product, FLQ-101, which aims to prevent retinopathy of prematurity (ROP). FLQ-101 can be administered ora ...