FDA issues SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertension.
Lilly and Incyte says they will resubmit their baricitinib NDA by the end of next January.
FDA approves a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating tardive dyskinesia in adults.
FDA says it will issue a guidance on how it evaluates real-world evidence in medical device regulatory decisions.
Federal Register notice: FDA makes available a draft revised guidance for industry on generic digoxin tablets.
Federal Register notice: FDA announces that it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydrochloride extended-rel...
FDA approves Novartis Kymriah as the nations first gene therapy, indicated for treating a form of leukemia in young patients.
FDA extends by three months a Biocon BLA for a proposed trastuzumab biosimilar product (Roches Herceptin), indicated for HER2-positive breast cancer a...