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Clinical - BLA/NDA/ANDA
FDA Extends NDA Review for Neuromed Pharmaceuticals's Exalgo(TM) Extended-Release Tablets 11/20/2009 8:31:56 AM    More...
FDA Panel Rejects Protein Sciences Corporation's Cell Culture Flu Vaccine, Wants More Safety Data 11/20/2009 8:45:32 AM    More...
Covidien (COV) Says FDA Extends Review of Opiod Pain Drug 11/20/2009 6:26:56 AM    More...
FDA Advisory Committee Finds Data Support the Claim That Pfizer Inc. (PFE)'s (JOBS) SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations 11/20/2009 6:52:10 AM    More...
EU Panel Blocks Merck KGaA (MKGAF.PK)'s (JOBS) Erbitux in Lung Cancer 11/20/2009 7:03:41 AM    More...
Merck & Co., Inc. (MRK) (JOBS) Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R) 11/20/2009 6:28:35 AM    More...
Dendreon Corporation (DNDN) (JOBS) Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010 11/20/2009 9:45:01 AM    More...
U.S. FDA Panel Rejects FDA and Genentech (South SF) (DNA)'s (JOBS) Xolair Asthma Drug for Children 11/19/2009 7:17:05 AM    More...
AstraZeneca PLC (AZN) (JOBS) Asks for U.S. Approval of Brilinta 11/19/2009 6:53:04 AM    More...
Astellas Pharma Inc. and XenoPort, Inc. (XNPT) Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome 11/19/2009 8:44:56 AM    More...
FDA Advisory Committee Finds Data Support the Safety and Effectiveness of Pfizer Inc. (PFE)'s (JOBS) Prevnar 13 Vaccine for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children 11/19/2009 7:15:16 AM    More...
FDA to Review Actelion Ltd. (ALIOF.PK)'s (JOBS) Zavesca for Additional Use 11/19/2009 6:56:09 AM    More...
Genentech (South SF) (DNA) (JOBS) and Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia 11/19/2009 7:26:54 AM    More...
Genzyme Corporation (GENZ)'s Pompe Drug Rejected--New Production Woes 11/17/2009 7:20:56 AM    More...
NicOx SA (NCOX.F) Announces FDA Accepts Naproxcinod NDA For Filing 11/18/2009 10:33:29 AM    More...
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