Federal Register notice: FDA determines that Tevas Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 m...
Spectranetics recalls its Bridge Occlusion Balloon due to the potential for a blocked guidewire lumen.
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.