- FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis
- FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
- Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
- Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name
- Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018
- Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
- Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration
- Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
- Acacia Pharma Resubmits Barhemsys New Drug Application
- 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
- Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections
- 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