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Sunesis Pharma Continues with AML Trial After DSMB Review

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Sunesis Pharmaceuticals says it is continuing a Phase 3 trial of vosaroxin in acute myeloid leukemia patients after receiving a f...

Sen. Coats Bill Would Reform FDA's Mission

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Sen. Dan Coats (R-IN) introduces a bill to clarify and reform FDA's mission in order to keep jobs from going overseas.

Info on DTC Advertising Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the experimental study of comparative direct-to-consu...

Device Panel Votes Down CardioMEMS Heart Monitor

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FDA's Circulatory Systems Devices advisory panel votes 6 to 4 to not recommend approval of a CardioMEMS PMA for the Champion Heart...

'Emerging Sponsors' Wreak Havoc on CDER Operations: FDAer

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CDER Office of New Drugs Director John Jenkins tells an industry audience that emerging sponsors are wreaking havoc on review acti...

FDA Panel Backs Ortho Evra; Asks for Clearer Labels

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An FDA advisory committee votes that the benefits of Janssen Pharmaceuticals Ortho Evra (norelgestromin/ethinyl estradiol transder...

Reviewers Raise Adasuve Safety Concerns

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FDA medical reviewers ask members of the Psychopharmacologic Drugs Advisory Committee to determine whether the benefits of Alexzas...

Plan B Decision Supports Authoritarian Control of America

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Editor Jim Dickinson sees in HHS secretary Kathleen Sebelius decision to over-rule FDA on Plan B a continuation of Bush-era author...

FDA OKs Watson/Antares NDA for Overactive Bladder

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FDA approves a Watson and Antares Pharma NDA for a topical oxybutynin gel 3% product to treat overactive bladder.

Advisors Back Pfizers Axitinib for Kidney Cancer

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FDAs Oncologic Drugs Advisory Panel recommends Pfizers axitinib for treating some advanced renal cell carcinoma patients.