Category - New Drug Applications
Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice
AcelRx Resubmits New Drug Application for DSUVIA
Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration
Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections
Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
Pfizer Granted FDA Breakthrough Therapy Designation for Trumenba (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
FDA Grants Breakthrough Therapy Designation For Genentech’s Hemlibra (emicizumab-kxwh) in Hemophilia A Without Inhibitors