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Neopharm Misses Phase 3 Endpoint with Cancer Drug

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Neopharm Inc. says a pivotal Phase 3 trial involving an experimental cancer drug failed to meet its efficacy endpoint.

FDA Action on Accomplia Set for April

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FDA sets a user fee action date of 4/26/07 for Sanofi-Aventis NDA resubmission on weight-loss drug Acomplia.

FDA, Baxter Warning on Heparin Thrombotic Events

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FDA and Baxter warn healthcare professionals about the possibility of delayed onset of heparin-induced thrombocytopenia.

FDA OKs IVX Animal sANADA

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Federal Register Final rule: FDA approves an IVX Animal Health supplemental ANADA to revise labeling of generic oxytetracycline to...

Gilead Will Comply with Subpoena, Probe

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The U.S. Attorney in San Francisco subpoenas marketing and medical education documents from Gilead Sciences for three HIV drugs.

Grassley Vows to Keep Fighting FDA Secrecy

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As incoming House Government Reform chairman Henry Waxman takes note, Sen. Chuck Grassley lambastes FDA secrecy and alleged intimi...

FDA OKs Velcades Use in MCL

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FDA approves a Millennium Pharmaceuticals supplemental NDA for Velcades use in treating relapsed mantle cell lymphoma.

FDA Approves Agri Labs ANADA for Airsacculitis

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Federal Register Final rule: FDA approves an Agri Laboratories ANADA that provides for oral use of lyncomycin and spectinomycin to...

OIG Wants More Effort on Human Subject Corrections

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The HHS Inspector General says FDA should do more to implement 2003 corrective actions called for by the commissioner to improve r...

Americans Unsure of Off-label Drug Use

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A Harris Interactive/Wall Street Journal Online poll finds that 62% of adults would support prohibiting off-label prescription dru...