FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTSD.
FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients wi...
FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for trans...
Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer complaint indicating that ...
HHS notifies over 3,000 FDA employees that their employment has been officially terminated effective 7/14.
FDA warns South Koreas Daewoo Pharmaceutical Co. about CGMP violations in its production of finished drugs.
A Benefits Pensions Monitor report says FDA drug inspection backlogs can hurt Canada since FDA has been performing 70% of Canadas drug manufacturing i...
FDA reviewers plan to ask an advisory committee this week about its concerns with ocular toxicity seen in trial data submitted by GSK in its BLA for B...
