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FDA, CMS Seek Device Review Pilot Participants

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Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services are seeking device sponsor participants for a pilo...

No Meeting Planned on Proprietary Name Pilot Program

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Federal Register Notice: Due to insufficient submissions, FDA will not hold a public meeting on the voluntary pilot program that e...

More Research on Rare Diseases, Products Urged

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Presenters at an orphan products and rare diseases conference call for more research on therapeutics for rare diseases; agree on t...

Will China Ban Growth-promoting Antibiotics?

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Online food safety reporters cant confirm a report that China plans to ban growth-promoting antibiotics in animal feed.

GlycoMimetic, Pfizer License Agreement on Sickle Cell Drug

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GlycoMimetics enters into an exclusive worldwide licensing agreement with Pfizer for GMI-1070, a pan-selectin antagonist currently...

FDA Approves Combivent Respimat with New Inhaler

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FDA approves a Boehringer Ingelheim Pharmaceuticals NDA for Combivent Respimat (ipratropium bromide and albuterol), a new propella...

Court Grants Restraining Order on Generic Lovenox

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Massachusetts federal court grants a temporary restraining order to prevent Watson Pharmaceuticals and Amphastar from marketing Am...

FDA 'Fast Track' for DARA Pain Drug

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FDA grants a fast track designation for DARA BioSciences' KRN5500 for treating neuropathic pain in patients with cancer.

FDA Approves Onco's Generic Cladribine

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FDA approves an Onco Therapies ANDA for a generic copy of Janssen's Luestatin.

Banner Pharmacaps ANDA for Generic Targretin

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FDA accepts for review a Banner Pharmacaps ANDA for a generic version of Eisai's Targretin.