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Clinical - BLA/NDA/ANDA
US Court Refuses Ranbaxy Laboratories (RANBAXY.BO) Appeal To Block ANDA Nod For 2 Drugs 11/26/2014 6:48:21 AM
Janssen Research & Development Submits New Drug Application For YONDELIS (trabectedin) To U.S. FDA For The Treatment Of Patients With Advanced Soft Tissue Sarcoma 11/25/2014 9:00:45 AM
Perrigo Company (PRGO) Confirms First To File Patent Challenge For Generic Version Of Aveed (Testosterone Undecanoate) Injection 11/24/2014 10:06:08 AM
IGI Laboratories, Inc. Announces ANDA Submission 11/24/2014 9:44:30 AM
Merck & Co. (MRK) Submits New Drug Application To The Japanese Pharmaceuticals And Medical Devices Agency For Omarigliptin, An Investigational Once-Weekly DPP-4 Inhibitor For Type 2 Diabetes 11/24/2014 9:33:08 AM
Janssen Research & Development Submits New Drug Application To U.S. FDA For Three-Month Paliperidone Palmitate 11/19/2014 11:44:57 AM
Pernix Therapeutics, Inc. (PTX) Submits sNDA For TREXIMET® Use In Adolescent Patients 11/17/2014 11:27:39 AM
Janssen Pharmaceutical Inc. Release: U.S. FDA Approves Supplemental New Drug Applications For Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (Paliperidone Palmitate) For The Treatment Of Schizoaffective Disorder 11/13/2014 9:14:36 AM
Actavis (ACT) Announces FDA Acceptance Of sNDA For SAPHRIS® (asenapine) For The Treatment Of Bipolar I Disorder In Pediatric Patients 11/13/2014 9:16:03 AM
FDA And European Medicines Agency Grant Orphan Designation To Xeris Pharmaceuticals ' Soluble Glucagon For Prevention Of Hypoglycemia In Congenital Hyperinsulinism Patients 11/12/2014 10:31:58 AM
FUJIFILM Holdings Corporation (FUJI) Expects Avigan To Be Approved For Ebola By End Of The Year 11/11/2014 6:19:06 AM
FDA Accepts Amgen (AMGN)'s Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab 11/10/2014 9:43:33 AM
Emergent BioSolutions (EBS) Seeks Expanded Biothrax Label; Submits FDA Application For Post-Exposure Prophylaxis 11/10/2014 8:19:05 AM
Rockwell Medical (RMTI) Surges As FDA Panel Recommends Triferic In Hemodialysis Patients 11/7/2014 6:15:49 AM
AVANIR Pharmaceuticals (AVNR)'s Migraine Treatment Will Unlikely Win Approval By Scheduled Timeline 11/7/2014 8:31:20 AM