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Clinical - BLA/NDA/ANDA
Perrigo Company (PRGO) Confirms First To File Patent Challenge For Generic Version Of Topicort® Topical Spray 0.25% 7/30/2014 8:29:27 AM
FDA Rejects Redwood City's AcelRx Pharmaceuticals (ACRX) Painkiller Dispensing Device; Stock Plunges -34.35% At 9:37AM ET 7/28/2014 6:17:43 AM
FDA Accepts For Review Adamis Pharmaceuticals (ADMP)' New Drug Application For Its Epinephrine Pre-Filled Syringe 7/29/2014 11:56:47 AM
Amgen (AMGN) Nervous As FDA Paves Way For Novartis AG (NVS) To Copy Drug Neupogen 7/24/2014 7:09:02 AM
Assembly Biosciences Provides Update On Status Of VEN 307 7/25/2014 8:05:50 AM
FDA Grants Genentech (RHHBY)’s Avastin Priority Review For Recurrent Platinum-Resistant Ovarian Cancer 7/22/2014 9:54:36 AM
Rich Pharmaceuticals Hires Contract Research Organization To File NDA And Identify Clinical Trial Site(S) For Lead Compound 7/23/2014 12:44:10 PM
Medicines360 And Actavis (ACT) Announce FDA Acceptance For Filing Of NDA For Levosert™ IUD 7/21/2014 12:07:21 PM
Medivir AB (MVRBF): FDA Has Granted Priority Review For OLYSIO® In Combination With Sofosbuvir Supplementary New Drug Application 7/15/2014 8:19:07 AM
Progenics Pharmaceuticals, Inc. (PGNX) Holds Conference Call This Morning On FDA Appeal Response Regarding Relistor® sNDA For Patients With Chronic Non-Cancer Pain 7/14/2014 6:07:51 AM
FDA Office Of Drug Evaluation III Approves Salix Pharmaceuticals, Ltd. (SLXP)’s Request That The FDA Approve The RELISTOR® Subcutaneous Injection sNDA For The Treatment Of Opioid-Induced Constipation In Patients With Chronic Non-Cancer Pain 7/14/2014 11:32:00 AM
Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO) Submit New Drug Application In The US For Brexpiprazole For The Treatment Of Schizophrenia And As Adjunctive Therapy For The Treatment Of Major Depressive Disorder 7/14/2014 8:24:21 AM
Janssen Pharmaceutical Inc. Seeks Expanded Label For Once-Monthly INVEGA® SUSTENNA® (paliperidone palmitate) To Show Delayed Time To Relapse Compared To Daily Oral Schizophrenia Therapies 7/14/2014 9:41:40 AM
Actavis (ACT) Confirms Generic Diclegis® Patent Challenge 7/14/2014 9:00:59 AM
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Acceptance Of NDA Filing For Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI) 7/14/2014 7:02:23 AM