Alkermes Receives U.S. FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Alkermes plc today announced that the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (nemvaleukin), has been granted Fast Track designation by ...
U.S. FDA Grants Orphan Drug Designation to Tesomet In Hypothalamic obesity (HO)
Saniona, a clinical-stage biopharmaceutical company focused on rare diseases, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) to treat hypothalamic obesity (HO) ...
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 ...