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). ...
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 ...
Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Genprex, Inc., today announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combinat ...
FDA grants AOC 1001 Fast Track Designation to treat Myotonic Dystrophy Type 1 (DM1).
AOC 1001, an investigational treatment for Myotonic Dystrophy Type 1 (DM1), a late-developing muscle disorder, has received fast track designation from the U.S. Food and Drug Administration (FDA). The ...
U.S. FDA has granted NuCana Fast Track Designation for Acelarin® for the Treatment of Biliary Tract Cancer.
Acelarin (NUC-1031), which is currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer, has been granted Fast Track desig ...
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 ...
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 ...
FDA Grants Fast Track Designation to MorphoSys AG’s Promising Endometrial Cancer Treatment
MorphoSys AG today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tulmimetostat, an innovative dual inhibitor targeting EZH2 and EZH1. This breakthro ...
FDA Grants Fast Track Designation to Bayer’s Asundexian for Stroke Prevention in Atrial Fibrillation Patients
Bayer has officially announced that the U.S. FDA has awarded Fast Track Designation to their investigational drug known as asundexian (BAY2433334). This designation recognizes its potential use as a t ...