FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.
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FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.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...
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.
