The new rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
ristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD).
Belgium-based Ablynx has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for approval of caplacizumab anti-von Willebrand factor (vWF) Nanobody to treat acquired thrombotic thrombocytopenic purpura (aTTP).