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FDA Clears Tyber Medical TyPeek Interbody Implant

[ Price : $8.95]

FDA clears a Tyber Medical 510(k) for TyPEEK and non-sterile and sterile PEEK (polyether ether ketone) interbody implant systems. ...

FDA Approves Bayers Adempas for Pulmonary Hypertension

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FDA approves Bayers Adempas to treat two forms of pulmonary hypertension.

Actavis Seeks Approval for Generic Suboxone

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Actavis files an ANDA to market a generic copy of Reckitt Benckisers Suboxone Sublingual Film (buprenorphine HCl and Naloxone HCl)...

Alkermes Taking Depression Drug to Phase 3

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Alkermes says it will open Phase 3 development early in 2014 for an investigational drug to treat major depressive disorder.

FDA OKs USGI Medical Endoscopic Weight Loss Study

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FDA grants conditional approval of USGI Medicals IDE application for the ESSENTIAL trial to study an outpatient incisionless endos...

Advisory Committee to Review Northera NDA in January

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FDA informs Chelsea Therapeutics that its NDA for Northera (droxidopa), indicated for treating symptomatic neurogenic orthostatic ...

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...