Rezolute, Inc. Receives FDA Orphan Drug Designation for Ersodetug for Hypoglycemia Due to Tumor Hyperinsulinism
Rezolute, Inc., a leading late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted ...
Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film Aquestive Therapeutics, Inc., a trailblazing pharmaceutical company dedicated to improving patients ...
FDA Accepts Cytokinetics’ NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy
FDA Accepts Cytokinetics' NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated today announced that the U.S. Food & Drug Administration (FDA) has accepted ...
FDA Grants Orphan Drug Designation to AAVantgarde Bio’s AAVB-081 for Usher Syndrome Type 1B Treatment
FDA Grants Orphan Drug Designation to AAVantgarde Bio's AAVB-081 for Usher Syndrome Type 1B Treatment AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company ...
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, ...