Category - New Drug Applications
US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia
Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke
Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla
Complete Response Letter from FDA for Barhemsys
Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)
RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019