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FDA Clears Kimberly-Clark Sterilization Wrap

[ Price : $8.95]

FDA clears a Kimberly-Clark 510(k) to allow use of its KimGuard One-step Sterilization Wrap with all Advanced Sterilization Produc...

FDA Plans Intraocular Lens Workshop

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 10/11: FDA/American Academy of Ophthalmology (AAO) Workshop on Developing Nov...

FDA Approves Abraxane for Late-stage Pancreatic Cancer

[ Price : $8.95]

FDA approves Eli Lillys Abraxane for treating late-stage pancreatic cancer.

GSK Cancer Trial Misses Co-primary Endpoint

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GlaxoSmithKline says its DERMA trial of the MAGE-A3 cancer immunotherapeutic failed to meet its first co-primary endpoint and will...

Advocacy Group Protests Guantanamo Reglan Force-Feeding

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Corporate Social Responsibility Advocate at Reprieve asks FDA to end force-feeding of Reglan at Guantanamo Bay and consider enforc...

Panel to Discuss 2 Grass/Pollen Allergen Tablets

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Federal Register Notice: FDAs Allergenic Products Advisory Committee will meet 11/15-16 to discuss Stallergenes Oralair and Mercks...

FDA Accepts Endo NDA Resubmission for Aveed

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FDA accepts for review an Endo Pharmaceuticals NDA resubmission for Aveed, the companys long-acting testosterone undecanoate injec...

CDER Finalizing Guidance on Biomarker Qualification

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A CDER official says the Center is finalizing a guidance on biomarker qualification and it should be released shortly.

FDA Approves Merck Bulk Varicella Manufacturing Site

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FDA approves Mercks Durham, NC, manufacturing facility to produce bulk varicella for use in chickenpox and shingles vaccines.

Calif. Senate Sends Biosimilars Substitution Bill to Governor

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The California Senate votes 30-2 to approve legislation to allow pharmacists to substitute biosimilars for branded biologics when ...