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Micromedics Recalls 3 Devices Over Sterility

[ Price : $8.95]

Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...

Gilead and Truvada Submit NDA for HIV Combo Pill

[ Price : $8.95]

Gilead Sciences files an NDA for a combination pill containing Truvada and Tibotec Pharmaceuticals investigational non-nucleoside ...

Vertex Completes Telaprevir NDA Submission

[ Price : $8.95]

Vertex says its telaprevir NDA submission is complete with results from three Phase 3 studies.

Gablofen Approved for Treating Spasticity

[ Price : $8.95]

FDA approves a CNS Therapeutics NDA for Gablofen (baclofen injection) for use in managing severe spasticity.

FDA Says Hologic Selenia System Approvable

[ Price : $8.95]

FDA issues an approvable letter for Hologics Selenia Dimensions 3-D digital mammography system.

Heart Failure Test Cleared by FDA

[ Price : $8.95]

FDA clears a BG Medicine 510(k) for the Galectin-3 test for use in conjunction with clinical evaluation to help assess the prognos...

More Recalls at McNeil Consumer Health Unit

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Johnson & Johnson's McNeil Consumer Health notifies FDA that it is recalling about 4 million packages of Children's Benadryl Fastm...

FDA Denies Propofol Petition

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FDA denies a citizen petition seeking enforcement action against Bedford Laboratories generic Diprivan for lack of conformity to c...

FDA Top Criminal Investigator to Retire

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FDA Office of Criminal Investigations director Terry Vermillion announces his retirement effective next month.

Quality System Violations Found at Eastern Cranial

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FDAs Baltimore District Office warns Eastern Cranial on Quality System and other violations associated with its KidCap Cranial Mol...