FDA Approves AbbVie’s VYALEV for 24-Hour Treatment of Advanced Parkinson’s Disease
AbbVie announced that the U.S. FDA has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in ...
Sangamo Therapeutics Gains FDA Pathway to Accelerated Approval for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, Inc., a genomic medicine company, announced the outcome of a recent successful interaction with the U.S. Food and Drug Administration. This interaction has provided a clear regul ...
FDA Grants Orphan Drug Designation to Remedy Pharma’s CIRARA for Treatment of Acute Ischemic Stroke
Remedy Pharmaceuticals, a pioneer in stroke drug development, has announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designati ...
EMA Grants Orphan Drug Designation to NIDO-361 for Kennedy’s Disease
Nido Biosciences, a biopharmaceutical company developing medicines to treat debilitating neurological diseases with precision, today announced that the European Medicines Agency has granted an Orphan ...
FDA Approves Astellas’ VYLOY for HER2-Negative Gastric and GEJ Adenocarcinoma
Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-containing chemot ...
Glaukos’ Epioxa Achieves Positive Phase 3 Results for Keratoconus Treatment
Glaukos Corporation announced that the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on) met its pre-specified primary efficacy endpoint. This next-generation corneal cross-linking iLink ...
Tonix Pharmaceuticals Submits NDA for TNX-102 SL to Treat Fibromyalgia
Tonix Pharmaceuticals Holding Corp. has announced the submission of a NDA to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, c ...
FDA Accepts UroGen’s NDA for UGN-102, Potential First Treatment for LG-IR-NMIBC
UroGen Pharma Ltd., a biotech company developing and commercializing innovative solutions for urothelial and specialty cancers, has announced the FDA acceptance of the New Drug Application (NDA) for U ...
FDA Grants Fast Track Designation to Valneva and LimmaTech’s Shigella4V Vaccine
Valneva SE, a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech firm focused on preventing life-threatening diseases, have announced that the U.S. Food and Drug Administr ...
European Commission Grants Orphan Designation to Theriva Biologics’ VCN-01 for Retinoblastoma
Theriva Biologics, a clinical-stage biotech company developing cancer therapeutics, announced that the European Commission has adopted the EMA's recommendation to grant orphan medicinal product design ...