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Panel to Discuss Erbitux and Vectibix Oncology Drugs

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/16.

Advisors Nix Arpidas Iclaprim

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FDAs Anti-infective Drugs Advisory Committee votes not to recommend approval of Arpidas intravenous antibiotic iclaprim.

Ortho Biotech Submits Trabectedin NDA

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Ortho Biotech submits an NDA to FDA for its trabectedin to be used in combination with Doxil to treat women with relapsed ovarian ...

FDA Corrects Notice on Amprolium Sponsors

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Federal Register Correction: FDA corrects an 8/6 notice designating sponsors of approved applications for oral dosage forms of amp...

Waxman Unseats Dingell on Energy and Commerce Committee

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House Democrats vote to replace long-serving Energy and Commerce Committee chair John Dingell (D-MI) with the committees second-in...

FDA Accepts Vanda Resubmission for Schizophrenia NDA

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FDA accepts for review a Vanda Pharmaceuticals NDA resubmission for iloperiodone that is its complete response to a 7/25 not appro...

FDA Clears Bovie Medical Tissue Resection Device

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FDA clears a Bovie Medical Corp. 510(k) for the Seer tissue resection device intended for initial use in liver oncology surgery.

Leucovorin, Levoleucovorin Shortage Info Updated

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FDA updates shortage information for Teva and Bedfords leucovorin products and Spectrums levoleucovorin.

FDA OKs Arcutis Pharma Acne Gel

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FDA approves an Arcutis Pharmaceuticals NDA for Acanya Gel, indicated for once-daily treatment of acne vulgaris.

Advisors Doubt Oritavancin Safety, Effectiveness

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FDAs Anti-infective Drugs Advisory Committee says, by a narrow vote, that Targantas oritavancin is not safe or effective for treat...