Archive - May 2018
Salix Receives FDA Approval for Plenvu, Next Generation 1-Liter Bowel Cleansing Preparation for Colonoscopies
FDA Moves to Overhaul New Drug Review Process
AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
FDA Grants Breakthrough Therapy Designation For Genentech’s Hemlibra (emicizumab-kxwh) in Hemophilia A Without Inhibitors
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
Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis