Category - New Drug Applications
Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Intra-Cellular Therapies Announces FDA Advisory Committee Meeting to Review the NDA for Lumateperone for the Treatment of Schizophrenia in Adults
Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019
Acer Therapeutics Receives Complete Response Letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS Patients
FDA Issues Complete Response Letter for Ryaltris NDA
RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia
Zogenix Announces FDA Agreement to Proceed with Resubmission of Fintepla NDA
Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation