Category - New Drug Applications
Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti
Liquidia Submits New Drug Application for LIQ861 (treprostinil) Inhalation Powder to FDA for the Treatment of Pulmonary Arterial Hypertension (PAH)
Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for Adlarity (donepezil transdermal system) for the Treatment of Alzheimer’s Disease
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
FDA Grants Priority Review of Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma
U.S. FDA Acknowledges Receipt of Evofem Biosciences’ New Drug Application Resubmission for Amphora for the Prevention of Pregnancy