- Trevena Receives Complete Response Letter for Oliceridine from FDA
- Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
- Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
- Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
- FDA Grants Priority Review for Sanofi’s Dengue Vaccine Candidate
- Acer Therapeutics Submits NDA for Edsivo (celiprolol) for the Treatment of Vascular Ehlers-Danlos syndrome (vEDS)
- ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV
- FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation
- Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for KPI-121 0.25% for Dry Eye Disease
- FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
- Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
- Bausch Health’s Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
- Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)
- FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
- U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review