FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients.
FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children.
Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that addresses FDA cited de...
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code to verify authenticit...
Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as drugs in the wake o...
FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine-containing products labeled as dietary supplements.
FDA approves a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-...