Five House Republicans write FDA commissioner Robert Califf about agency safeguards in place when questionable foreign-made generic drugs are allowed ...
FDA sends Alvotech a second complete response letter on its BLA for AVT02, a biosimilar candidate referencing AbbVies Humira (adalimumab), based on ma...
Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received for its HyBryte (synthetic hypericin) NDA for lympho...
FDA clears a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis.
FDA posts a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection.
The Justice Department seeks emergency relief from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled that the abortion drug mifepr...
Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content.
Federal Register notice: FDA announces a request for information and comments on the development of an FDA data and technology strategic plan.
