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FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.[ Price : $8.95]
FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.[ Price : $8.95]
FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT ca...[ Price : $8.95]
FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTS...[ Price : $8.95]
FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomip...[ Price : $8.95]
FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...[ Price : $8.95]
Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...[ Price : $8.95]
FDA warns South Koreas Daewoo Pharmaceutical Co. about CGMP violations in its production of finished drugs.