FDA approves a new Boxed Warning on canagliflozin (Janssens Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) based on recent safety data t...
Mylan asks FDA to deny a Mayne Pharma petition seeking to impose additional requirements on ANDAs referencing Maynes Doryx MPC delayed-release tablets...
Federal Register notice of technical amendment: FDA amends a final rule on Civil Money Penalty Definitions.
CDER issues a MAPP clarifying roles and responsibilities of the Office of Biotechnology Products and the Office of Process and Facilities in assessing...
Federal Register notice: FDA announces the availability of a guidance on M4E(R2): The CTD Efficacy, an International Council for Harmonization revise...
Celgene agrees to pay $280 million to settle a False Claims Act suit related to the promotion of two cancer treatment drugs for unapproved uses.
FDA sends Eagle Pharmaceuticals a complete response letter on its 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke.
FDA releases the FDA-483 with 11 observations from an inspection at Bella Pharmaceuticals.