FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.
FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.
FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT carcinoma in patients ...
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 ...
FDA warns South Koreas Daewoo Pharmaceutical Co. about CGMP violations in its production of finished drugs.
