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FDA Sends Info on Rx Drug Labeling to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on prescription d...

GSK, Merck Team Up on Combo Trial Against Tumors

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GlaxoSmithKline and Merck begin a Phase 1 clinical trial designed to evaluate GSKs investigational immunotherapy GSK3174998 as a m...

FDA Approves INVO Bio Vaginal Fertility Incubator

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FDA approves an INVO Bioscience de novo petition to allow the marketing of the INVOcell, an intravaginal culture system for use in...

Novartis Settlement Shows Focus on PBMs

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Attorneys say a recent Novartis settlement of civil kickback claims demonstrates the Justice Departments enforcement focus on phar...

Court Should Retreat from Wyeth Decision: Troy

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Former FDAer Daniel Troy calls on the Supreme Court to back away from its Wyeth v Levine decision and allow much more preemption o...

Expedited Pathway Granted to Wearable Artificial Kidney

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FDA grants an Expedited Access Pathway designation for the first Wearable Artificial Kidney which was invented by UCLA/Cedars Sina...

Sanofi, BioNTech Partner to Develop 5 Immunotherapies

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Sanofi and BioNTech enter into a multiyear collaboration and license agreement to discover and develop up to five cancer immunothe...

OMB OKs Info on Blood Cell Separator

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a special controls guidance o...

Health Canada, FDA Webinar on Pharmaceuticals

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Federal Register Notice: FDA will hold a regional public webinar 11/12 on Health Canada and U.S. FDA joint public consultations on...

FDAs Science Board to Meet

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Federal Register Notice: FDAs Science Board will meet 11/18 to hear topics such as precision medicine, and health informatics init...