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...
Nipro recalls its MedicaLyte liquid bicarbonate concentrate after confirming bacterial and fungal contamination in returned products.
FDA delays a review decision on a KalVista Pharmaceuticals NDA for sebetralstat, indicated for treating hereditary angioedema.
FDA says a Medtronic recall of specified Newport ventilators is Class 1.
