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 ...
Anavex Life Sciences Reports Positive Results from ANAVEX®3-71 Phase 1 Clinical Trial
A phase 1 study of ANAVEX 3-71, an oral small molecule agonist of SIGMAR1 and CHRM1, met its primary safety and secondary endpoint, Anavex Life Sciences recently announced. The drug is in development ...
CARsgen Announces CT041 Granted RMAT Designation by the FDA
CARsgen Therapeutics Holdings Limited, a company primarily focused on developing novel CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today that CT041 h ...
Atriva receives FDA Orphan Drug Designation for Zapnometinib to treat Hantavirus Infections
Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, announced today that its lead candidate, zapnometinib (ATR-002), has received Or ...
FDA approves treatment for schizophrenia in pediatric patients
Otsuka and Lundbeck's supplemental new drug application (sNDA) for brexpiprazole to treat schizophrenia in pediatric patients aged 13 to 17 years has been approved by the US Food and Drug Administrati ...