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Clinical - BLA/NDA/ANDA
Hutchison Chi-Med To File For Approval Of Two Cancer Drugs In 2016 3/3/2015 7:36:07 AM
Shares Fall as the FDA Rejects Pacira (PCRX)'s Application for Expanded Use of Pain Drug 3/2/2015 6:14:06 AM
Bristol-Myers Squibb (BMY) Release: U.S. FDA Accepts Biologics Licensing Application For Opdivo (Nivolumab) For The Treatment Of Advancedsquamous Non-Small Cell Lung Cancer 3/2/2015 11:46:20 AM
Alexion Pharmaceuticals Inc. (ALXN) Release: FDA Grants Priority Review For Asfotase Alfa As A Treatment For Patients With Hypophosphatasia 3/2/2015 11:36:57 AM
Newron Pharmaceuticals (NWRN) Release: Xadago (Safinamide) New Drug Application (NDA) Accepted For Filing By The FDA 3/2/2015 11:18:52 AM
Cardio3 BioSciences Marks First Important Milestone In Regulatory Path Toward C-Cure Market Registration With Paediatric Investigation Plan Waiver From European Medicines Agency 3/2/2015 10:18:07 AM
Boehringer Ingelheim Submits Biologics License Application To FDA For Idarucizumab, Investigational Specific Reversal Agent For Pradaxa (Dabigatran Etexilate Mesylate) 3/2/2015 7:34:49 AM
Shire (SHPGY) Submits Application To The U.S. D&A Pharma For Approval Of Lifitegrast For Treatment Of Dry Eye Disease In Adults 3/2/2015 7:00:49 AM
Pacira Pharmaceuticals, Inc. (PCRX) Receives Complete Response Letter From FDA For sNDA Seeking Approval Of EXPAREL Use In Nerve Block To Provide Postsurgical Analgesia 3/2/2015 6:15:17 AM
FDA Advisory Committee Recommends Approval For Avedro, Inc.’S Riboflavin Ophthalmic Solutions With UVA Irradiation For Corneal Collagen Cross-Linking To Treat Progressive Keratoconus And Corneal Ectasia 2/27/2015 10:36:39 AM
Otsuka Pharmaceutical Co., Ltd. Release: CHMP Recommends Jinarc (Tolvaptan) For Approval In EU: The First Pharmaceutical Treatment For Autosomal Dominant Polycystic Kidney Disease (Adpkd) 2/27/2015 8:22:32 AM
Otonomy, Inc. (OTIC) Submits New Drug Application To The FDA For Auripro 2/26/2015 7:53:58 AM
Teva Pharmaceutical Industries (TEVA) Announces FDA Acceptance For Review Of NDA For Its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets With Proprietary Abuse Deterrence Technology 2/25/2015 10:36:08 AM
Relmada Therapeutics Announces Filing Of Clinical Trial Application In Canada For Novel Oral Formulations Of Buprenorphine 2/24/2015 6:31:13 AM
Eli Lilly (LLY) Announces Update On Regulatory Submission Timing For Basal Insulin Peglispro 2/23/2015 7:10:01 AM