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Orphan Status for Liver Transplant Drug

[ Price : $8.95]

FDA grants Conatus Pharmaceuticals an orphan drug designation for emricasan and its use in treating liver transplant recipients wh...

Sumitomo Proton Therapy System Clears FDA 510(k)

[ Price : $8.95]

FDA grants 510(k) clearance to Sumitomo Heavy Industries for its Proton Therapy System to kill cancer cells.

Info on Medically Necessary Products Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget in a guidance on ...

FDA Study Finds Gaps in Pertussis Vaccine Protection

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FDA researchers say acellular pertussis vaccines are effective in preventing disease but not as effective in preventing infection ...

FDA Follows Advisors Votes 86% of the Time: Study

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A McKinsey analysis finds that FDA follows recommendations of advisory committees to approve or not approve an NDA or BLA nearly 9...

Priority Review for Durata NDA for Skin Infections

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FDA accepts for priority review a Durata Therapeutics NDA for Dalvance (dalbavancin hydrochloride) for injection for treating pati...

FDA Fast Track for VBL Brain Cancer Drug

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FDA grants VBL Therapeutics a fast track designation for its lead oncology drug VB-111 and its use in prolonging survival in patie...

FDA Asked for New Homeopathic Drug Marketing Rules

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Former FDA Office of Regulatory Affairs manager William Schwemer asks FDA to issue new rules governing marketing of homeopathic dr...

FDA Hits 2nd Wockhardt Plant with Import Alert

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FDA issues an import alert for most generic drugs manufactured at Wockhardts Chikalthana facility.

Baxter Recalls 1 Nitroglycerin Lot

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Baxter recalls one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.