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FDA Approves Glaxos Fluarix Quadrivalent Vaccine

[ Price : $8.95]

FDA approves a GlaxoSmithKline BLA for Fluarix Quadrivalent (influenza virus vaccine) for the immunization of children (three year...

Report Finds Obstacles to Biosimilar Pathway Adoption

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A new Congressional Research Service report on FDAs biosimilars pathway finds that navigating the approval path will be an arduous...

FDA Fast Track for IBS Drug

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FDA grants fast track status to Lexicon Pharmaceuticals for LX1033, an orally-delivered small molecule drug candidate for diarrhea...

Ariad Leukemia Drug Approved 3 Months Ahead of Schedule

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Three months ahead of its user fee review date, FDA approves an Ariad Pharmaceuticals NDA for Iclusig to treat adults with two for...

Anthrax Therapy Approved by FDA

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FDA approves Human Genome Sciences raxibacumab injection to treat inhalational anthrax.

Hamburg Seeks More Pre-competitive Collaboration in R&D

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FDA commissioner Margaret Hamburg says that that if academia, industry, government scientists and regulators could come together m...

Regulators Policy Issues in Litigation Discussed

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Representatives from FDA, the Centers for Medicare and Medicaid Services and Department of Justice discuss policy considerations a...

Agency Accepts Actelion NDA for Pulmonary Arterial Hypertension

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FDA accepts an Actelion NDA for Opsumit (macitentan), indicated for treating patients with pulmonary arterial hypertension.

Bayer Files NDA for Prostate Cancer

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Bayer HealthCare submits an NDA for radium Ra 223 dichloride, an investigational compound for treating castration-resistant prosta...

FDA Rejects Jazz Pharma Petition on Xyrem REMS

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FDA denies a Jazz Pharmaceutical citizen petition that asked the agency to not accept any ANDA referencing its Xyrem that did not ...