Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav
BERKELEY, CA -- (Marketwire) -- 11/15/12 -- Dynavax Technologies Corporation today announced that the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee...
View ArticleZogenix Announces FDA Advisory Committee Review of Zohydro ER for the...
SAN DIEGO, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc., a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today...
View ArticleOrexo announces that Zubsolv has been accepted for review by the U.S. Food...
UPPSALA, Sweden--(BUSINESS WIRE) November 19, 2012 -- FDA has informed Orexo (STO:ORX) that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee...
View ArticleAVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the...
CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)--Nov 28, 2012 - AVEO Oncology and Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New...
View ArticleForest Laboratories Submits New Drug Application for Cariprazine for the...
NEW YORK & BUDAPEST, Hungary--(BUSINESS WIRE)--Nov 28, 2012 - Forest Laboratories, Inc. and Gedeon Richter Plc. announced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and...
View ArticleZogenix Provides Update on FDA Advisory Committee Meeting for Zohydro ER for...
SAN DIEGO, Dec. 7, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc., a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today...
View ArticleFDA Accepts Takeda and Lundbeck's Submission of the New Drug Application for...
DEERFIELD, Ill., Dec. 12, 2012 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug...
View ArticleActelion Announces acceptance of the New Drug Application for macitentan by...
ALLSCHWIL/BASEL, SWITZERLAND - 14 December 2012 - Actelion (SIX: ATLN) today announced that the Food and Drug Administration (FDA) in the United States (US) has officially accepted the New Drug...
View ArticleLexicon's Drug Candidate For Irritable Bowel Syndrome (LX1033) Receives Fast...
THE WOODLANDS, Texas, Dec. 17, 2012 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease,...
View ArticleViiV Healthcare Announces Regulatory Submissions for Dolutegravir in the EU,...
London, UK - 17 December, 2012 -- ViiV Healthcare today announced the submission of regulatory applications in the European Union (EU), United States (US) and Canada for the investigational integrase...
View ArticleRaptor Pharmaceutical Corp. Provides Update on Procysbi NDA Review
NOVATO, Calif., Dec. 21, 2012 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced that the U.S. Food and Drug Administration ("FDA") will require additional...
View ArticleFDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue...
PHILADELPHIA, Dec. 21, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (the "Company" or "Hemispherx") today announced the outcome of the meeting of the Arthritis Advisory Committee (the "AAC") of...
View ArticleMerck Announces FDA Acknowledgement of Resubmission of New Drug Application...
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 2, 2013 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has...
View ArticleMerck Announces FDA Acceptance of Resubmission of New Drug Application for...
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 7, 2013 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA)...
View ArticleGE Healthcare Announces Acceptance of Applications for Review of...
PRINCETON, N.J.--(BUSINESS WIRE)--Jan 8, 2013 - GE Healthcare today announced that regulatory bodies in the United States and Europe have accepted its applications for review of the investigational PET...
View ArticleFDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of...
RARITAN, N.J., Jan. 10, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug...
View ArticleGSK Announces Submission of Albiglutide BLA to the US FDA for the Treatment...
GlaxoSmithKline (GSK) plc today announced a regulatory submission to the US Food and Drug Administration (US FDA) for albiglutide, an investigational once-weekly treatment for adult patients with type...
View ArticleU.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for...
RIDGEFIELD, Conn., Jan. 15, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib...
View ArticleQRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug...
SYDNEY and BEDMINSTER, N.J., Jan. 16 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the steps necessary for approval of immediate release MoxDuo have been...
View ArticleFDA Issues Complete Response Letter for Rytary (Carbidopa and Levodopa)...
HAYWARD, Calif.--(BUSINESS WIRE)--Jan 21, 2013 - Impax Pharmaceuticals, a division of Impax Laboratories, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a complete...
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