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FDA OKs IND for Ulcerative Colitis Candidate

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FDA approves an Avaxia Biologics IND for AVX-470 for treating of ulcerative colitis.

Doryx Reformulations May be Anti-competitive: FTC

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The Federal Trade Commission supports Mylans lawsuit contending that Warner Chilcott used product reformulations to delay market e...

FDA Orphan Status for Seattle Genetics Drug

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FDA grants an orphan drug designation to Seattle Genetics Adcetris (brentuximab vedotin) for treating mycosis fungoides.

Guidance on HIV-Preventing Microbicides

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Federal Register Notice: FDA releases a draft guidance, Vaginal Microbicides: Development for the Prevention of HIV Infection.

FDA Posts Planned CDRH Guidances

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Federal Register Notice: FDA posts a Web site location for FY 2013 planned CDRH guidance documents.

Risk Communication Advisory Panel to Meet

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 2/12 to discuss general risk communication factors. ...

FDA Green Light for Kidney Transplant Trial

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FDA gives Isotechnika Inc. permission to begin the first of two planned Phase 3 kidney transplant trials for its lead product cand...

Ranbaxy Under Scrutiny After Generic Lipitor Recall

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Ranbaxy recalls dozens of lots of generic Lipitor after detecting small glass particles in some batches, a move that is likely to ...

Deka Petition Seeks Stair Wheelchair Reclassification

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Deka Research and Development Corp. petitions FDA to reclassify stair-climbing wheelchairs from Class 3 to Class 2 devices.

FzioMed Appeals CDRH PMA Denial of Oxiplex/SP Gel

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FzioMed seeks dispute panel resolution of a CDRH decision to deny approval for its PMA for Oxiplex/SP Gel for use in back surgery.