Category - New Drug Applications
FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome
Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
Alkermes Receives Refusal to File Letter From FDA for ALKS 5461
Antares Pharma Provides Xyosted Regulatory Update