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Clinical - BLA/NDA/ANDA
FDA Postpones Its Final Decision On NPS Pharmaceuticals, Inc. (NPSP)'s Natpara 10/24/2014 6:08:43 AM
FDA Panel Unanimously Backs Novartis AG (NVS)' Psoriasis Drug 10/20/2014 3:34:36 PM
Alkermes plc (ALKS)’ New Drug Application For Aripiprazole Lauroxil For Treatment Of Schizophrenia Accepted For Filing By U.S. FDA 10/22/2014 9:19:19 AM
Synageva BioPharma (GEVA) Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa 10/22/2014 8:09:52 AM
Relypsa, Inc. (RLYP) Submits New Drug Application To U.S. FDA Seeking Approval For Patiromer For Oral Suspension To Treat Hyperkalemia 10/22/2014 7:22:54 AM
Analysts Predict FDA Approval Of Novo Nordisk A/S (NVO)'s Obesity Drug By Year-End 10/21/2014 5:51:12 AM
BioSpecifics Technologies Corporation (BSTC) Announces FDA Approval Of sBLA For XIAFLEX® For The Concurrent Treatment Of Two Dupuytren's Contracture Cords 10/21/2014 8:22:41 AM
Auxilium Pharmaceuticals (AUXL) Announces XIAFLEX Now Approved For The Concurrent Treatment Of Up To Two Affected Joints In The Same Hand In Dupuytren's Contracture Patients 10/21/2014 7:32:54 AM
Eisai Inc. (ESALF.PK) Announces FDA Acceptance Of Supplemental New Drug Application For Antiepileptic Drug Perampanel As Adjunctive Treatment Of Primary Generalized Tonic-Clonic Seizures 10/20/2014 9:02:51 AM
Pharmacyclics, Inc. (PCYC) Files Supplemental New Drug Application For IMBRUVICA® For Waldenstrom's Macroglobulinemia 10/20/2014 8:29:51 AM
FDA Accepts For Review A Biologics License Application For Merck & Co. (MRK) And Sanofi Pasteur (SASY.PA)’s Investigational Pediatric Hexavalent Vaccine 10/20/2014 7:51:47 AM
Janssen Research & Development Release: IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted To The U.S. FDA For Waldenstrom's Macroglobulinemia 10/20/2014 7:23:33 AM
Matinas BioPharma Submits Investigational New Drug Application For Lead Product Candidate MAT9001 For The Treatment Of Severe Hypertriglyceridemia 10/20/2014 6:17:27 AM
Novartis AG (NVS) Psoriasis Drug Secukinumab Benefits Outweighs Risk: FDA Staff 10/17/2014 5:55:48 AM
Repros Therapeutics Inc. (RPRX) Shares Tank On Drug Application Setback 10/17/2014 7:15:39 AM
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