Category - New Drug Applications
Acacia Pharma Resubmits Barhemsys New Drug Application
Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
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
Acer Therapeutics Submits NDA for Edsivo (celiprolol) for the Treatment of Vascular Ehlers-Danlos syndrome (vEDS)
Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
Trevena Receives Complete Response Letter for Oliceridine from FDA