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FDA Grants Novoteris Orphan Status for Nitric Oxide

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FDA grants Novoteris an orphan drug designation for its inhaled nitric oxide and its use in treating cystic fibrosis.

FDA Clears Tyber Medical TyPeek Interbody Implant

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

$26 mil. FDA Contract for Drug Labeling Conversion

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FDA signs a $26 million contract with Reed Technology and Information Services to convert Rx drug labeling to the Physician Labeli...

Clinical Hold on Iclusig Trial Enrollment

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FDA places a clinical hold on enrollment of new patients in Clinical trials of Ariad Pharmaceuticals Iclusig.

Advisors Support Medtronic Pacing Devices

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Members of FDAs Circulatory Systems Devices Advisory Panel vote to recommend an expanded indication for Medtronic biventriocular p...

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 ...