New Drug Applications Archive - September 2016
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September 1, 2016
- Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment
- Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma
September 2, 2016
September 6, 2016
- BioMarin Announces Update to Brineura (cerliponase alfa) Program for Treatment of CLN2 Disease, a Form of Batten Disease
- Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%
September 12, 2016
September 14, 2016
- FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
- FDA Advisory Committee Votes that Qapzola (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo
September 19, 2016
September 20, 2016
September 22, 2016
September 23, 2016
September 26, 2016
- Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy
- Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
- Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
- Pain Therapeutics Receives Complete Response Letter for Remoxy ER
