ChemomAb’s CM-101 Receives FDA Clearance for Phase 2 trial in Adults with Systemic Sclerosis (SSc)
ChemomAb Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application to assess CM-101 in a Phase 2 trial for systemic sclerosis (SSc ...
Biohaven’s Taldefgrobep Alfa Receives Fast Track Designation from FDA for Treating Spinal Muscular Atrophy
Biohaven Ltd. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel anti-myostatin adnectin, taldefgrobep alfa, for treating spinal muscular atrophy (SMA). ...
Opthea’s Phase 2b Results of OPT-302 Combo Therapy Published in Ophthalmology: A Promising Treatment for Wet AMD
Opthea Limited, a clinical-stage biopharmaceutical company, has disclosed that the Phase 2b clinical trial results of OPT-302, their anti-VEGF-C/-D "trap" agent given together with Lucentis® (ranibizu ...
U.S. FDA Grants Fast Track Designation to Artiva Biotherapeutics’ Lead Program AB-101
Artiva Biotherapeutics, Inc., a clinical-stage company whose mission is to provide highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announces that the U.S. FDA has ...
Ionis Pharma’s Olezarsen Receives FDA Fast Track Designation for Familial Chylomicronemia Syndrome (FCS) Treatment
Ionis pharmaceuticals receives fast-track designation from U.S. Food and drug administration (FDA) for olezarsen in Familial chylomicronemia syndrome (FCS) treatment. Olezarsen (formerly IONIS-APOCIII ...
FDA Accepts Blueprint Medicine’s AYVAKIT® Supplemental NDAs for Treatment of Indolent Systemic Mastocytosis
Blueprint Medicines announces FDA acceptance of AYVAKIT® supplemental NDA for indolent systemic mastocytosis treatment. FDA grants priority review with May 22, 2023 action date under PDUFA. Results fr ...