[ Price : $8.95]
Lilly and Incyte says they will resubmit their baricitinib NDA by the end of next January.[ Price : $8.95]
FDA approves a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating tardive dyskinesia in adults...[ Price : $8.95]
FDA says it will issue a guidance on how it evaluates real-world evidence in medical device regulatory decisions.[ Price : $8.95]
Federal Register notice: FDA makes available a draft revised guidance for industry on generic digoxin tablets.[ Price : $8.95]
Federal Register notice: FDA announces that it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydroc...[ Price : $8.95]
FDA approves Novartis Kymriah as the nations first gene therapy, indicated for treating a form of leukemia in young patients.[ Price : $8.95]
FDA extends by three months a Biocon BLA for a proposed trastuzumab biosimilar product (Roches Herceptin), indicated for HER2-posi...[ Price : $8.95]
FDA releases the FDA-483 with two observations from a 2016 inspection at Wickliffe Pharmaceutical.