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Intal Capsule Not Withdrawn for S&E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Federal Register Notice: FDA determines that Intal Inhalation Capsule, 20 mg was not withdrawn from sale for reasons of safety or ...

Paraflex Not Withdrawn for S&E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Federal Register Notice: FDA determines that Paraflex tablets, 250 mg were not withdrawn from sale for reasons of safety or effect...

Potassium Citrate Not Withdrawn for S&E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Federal Register Notice: FDA determines that Nova-K LLCs potassium citrate, 10 mEq/packet and 20 mEq/packet was not withdrawn for ...

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...

Panel to Discuss Potential Pediatric Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/5 to the development of three products for potential pe...

Merck Breakthrough Designation for Hepatitis C Therapy

[ Price : $8.95]

FDA grants Merck a breakthrough therapy designation for MK-5172/MK-8742 for treating chronic hepatitis C virus infection.

Pediatric Oncology Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/4 to discuss FDAs position on patient-reported outcomes...

CDER MAPP on Clearing Articles, Speeches

[ Price : $8.95]

CDER issues a MAPP outlining policies for internal clearing of articles, speeches, and other communications written by Center empl...