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Priority Review for Lilly Gastric Cancer Therapy BLA

[ Price : $8.95]

FDA assigns a priority review for an Eli Lilly BLA for IMC-1121B (ramucirumab) as a single-agent treatment for advanced gastric ca...

FDA Approves Allergans Juvederm For Cheek Area

[ Price : $8.95]

FDA approves Allergans Juvederm Voluma XC, a dermal filler for temporarily correcting age-related volume loss in the cheek area in...

Codman and Shurtleff Pump Recall Class 1

[ Price : $8.95]

FDA says a recall of Codman and Shurtleff MedStream infusion pumps is Class 1.

FDA Completing Phase-out of CFC Inhalers

[ Price : $8.95]

FDA says its phase-out of medical inhalers with chlorofluorocarbon propellants will be completed by 12/31.

Correction on Fibromyalgia Meeting Comments

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Federal Register Notice: FDA corrects dates for submission of comments from a 9/23 Federal Register notice on a public meeting on ...

Panel to Discuss BioMarin BLA for Vimizim

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/19 to discuss a BioMarin BLA for ...

FDA Withdraws Certain Bexxar Indication

[ Price : $8.95]

Federal Register Notice: FDA withdraws an indication for GlaxoSmithKlines Bexxar because a postmarketing study that was a conditio...

Intal Capsule Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Intal Inhalation Capsule, 20 mg was not withdrawn from sale for reasons of safety or ...

Paraflex Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Paraflex tablets, 250 mg were not withdrawn from sale for reasons of safety or effect...

Potassium Citrate Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Nova-K LLCs potassium citrate, 10 mEq/packet and 20 mEq/packet was not withdrawn for ...