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 ...