New Drug Applications Archive - February 2015
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February 2, 2015
February 3, 2015
- U.S. FDA Grants Priority Review for Yondelis (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma
- Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma
February 9, 2015
- Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo
- Inspirion Delivery Technologies Announces FDA Acceptance of MorphaBond ER (morphine sulfate extended-release) NDA
February 11, 2015
February 12, 2015
- Lenvatinib Phase III Trial Results Published in New England Journal of Medicine
- Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone)
February 13, 2015
- Pfizer Announces FDA Acceptance for Review of NDA for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)
- Novartis' Heart Failure Medicine LCZ696 Granted FDA Priority Review
February 17, 2015
- Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women
- Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from FDA for Reolysin for Pancreatic Cancer
February 18, 2015
February 23, 2015
- Taiho Oncology, Inc. Announces TAS-102 NDA for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA
- Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain
