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House Passes Temporary FDA Budget

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The U.S. House of Representatives votes 235-162 to pass a short-term FDA budget to allow furloughed employees to return to work, b...

FDA Cancels Merck BLA Advisory Panel Review Due to Shutdown

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FDA cancels an 11/6 Allergenic Products Advisory Committee meeting that was set to review Mercks BLA for Grastek, a Timothy Grass ...

FDA Accepts Keryx NDA for Zerenex

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FDA accepts for review a Keryx Biopharmaceuticals NDA for Zerenex (ferric citrate coordination complex) for use in patients with c...

Cubist Pharma: New Molecules Active Against Superbugs

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Cubist Pharmaceuticals and Spains Fundacin MEDINA say they have discovered a new family of natural molecules that have shown activ...

Look at How Policies Affect Drug Development: PhRMA

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PhRMA president John Castellani says its important to consider how public policies may affect patient care and drug development in...

Fabius Anesthesia Machines Recalled

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FDA says Drger is recalling specific Fabius anesthesia machine units that may have a power supply problem.

Hospira Recalls 1 Lot of Injectable Lidocaine

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In its sixth such action since May, Hospira recalls one lot of 1% lidocaine HCI injection due to a confirmed customer report of vi...

QS Violations Found at Batrik Medical

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FDA warns Batrick Medical about Quality System violations in its manufacturing of vascular silicon ties.

Court Dismisses Hip Replacement Suit Against DePuy

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A Pennsylvania federal court dismisses a suit against DePuy Orthopedics alleging injuries due to a defective replacement hip.

FDA Clears Advanced Catheter for Occlusion Perfusion Catheter

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FDA clears an Advanced Catheter Therapies 510(k) for its Occlusion Perfusion Catheter.