Category - New Drug Applications
TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR
FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program
Santen Receives Complete Response Letter from U.S. FDA for Intravitreal Sirolimus (DE-109)
Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea
Loxo Oncology Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancers
GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
TherapeuticsMD Announces Submission of New Drug Application for TX-001HR
Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation