FDA delays a review decision on a KalVista Pharmaceuticals NDA for sebetralstat, indicated for treating hereditary angioedema.
FDA approves Mercks Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults wit...
FDA places a clinical hold on a Rein Therapeutics Phase 2 (RENEW) trial of LTI-03 due to agency requests for additional non-clinical information.
FDA posts a final guidance entitled ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.
Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-consumer drug advertising.
FDA schedules a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab mafodotin) for treating...
FDA says a Medtronic recall of specified Newport ventilators is Class 1.
The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Immunization Practices ...
