Category - New Drug Applications
FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy
FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)
Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States