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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...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Family Pharmacy and Sound Healing Arts, PC, dba Grounds for Tea.

FDA Breakthrough Status for Mercks Keytruda

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FDA grants Merck a breakthrough therapy designation for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with ...

Vertex Pharma Receives Subpoena Over GLPs

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Vertex Pharmaceuticals says it received a subpoena from the U.S. Department of Justice in the third quarter related to its Good La...

OIG Aims to Examine Post-marketing Requirements

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HHS Office of Inspector General plans to examine how FDA requires NDA holders to conduct postmarketing studies and the agencys ove...

FDA Grants Expedited Access Designation for MyoRegulator

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FDA grants PathMaker Neurosystems an Expedited Access Pathway designation for its MyoRegulator PM-2200 system for use in treating ...

Guidance on Dispenser Product Tracing Requirements

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Federal Register Notice: FDA issues a revised guidance: DSCSA Implementation: Product Tracing Requirements for Dispensers Complia...