BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresectable, recurrent, lo...
A supplemental NDA for Novo Nordisks weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication is withdrawn to add additional d...
FDA tells the DC District Court that a recent Novartis lawsuit that seeks a preliminary injunction to reverse the agencys approval of MSN Laboratories...
FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by a contract manufact...
FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatric Patients to discus...
The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced to two years in fed...
Foundation Medicine petitions FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection t...
