Incyte reports the first positive clinical data from studies evaluating a novel, first-in-class targeted monoclonal antibody in patients with mutant c...
FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.
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 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.
