New Drug Applications Archive - April 2015
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April 7, 2015
April 9, 2015
April 13, 2015
- Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD
- ARCA Biopharma Receives FDA Fast Track Designation for Gencaro
April 15, 2015
- Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA
- FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor
April 17, 2015
- Results of Phase III Study of Brexpiprazole in Adult Patients With Schizophrenia Published in American Journal of Psychiatry
- Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the FDA for Malignant Gliomas
April 23, 2015
- Ultragenyx Granted Additional Orphan Drug Designations for Triheptanoin
- FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab
April 27, 2015
- Merrimack Pharmaceuticals and Baxter BioScience Announce Completion of NDA Submission for MM-398 as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer
- BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy
April 28, 2015
- Otonomy Announces FDA Acceptance of AuriPro New Drug Application
- Merck Receives Complete Response Letter for Sugammadex Sodium Injection
