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Human Drugs

CGMP Violations at Exela Pharma Sciences

FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.

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Human Drugs

Support for Biosimilar Legislation

Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the distinction between ...

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Human Drugs

FDA Prodded to Improve Surrogate Endpoint Transparency

A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to increase surrogate endpo...

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Human Drugs

Taiho Reports Unfavorable DMD Drug Data

Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchenne muscular dystroph...

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FDA General

FDA Urged to Expand Real-World Data Use

A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of ...

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Medical Devices

Multiple Insightra Medical Violations Cited

FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump catheter kits with specific...

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Human Drugs

FDA Study Finds Liver Risks Associated with CBD

A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concerns about the safety o...

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Medical Devices

Expanded Parkinsons Use OKd for Insightec Device

FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients livin...

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Human Drugs

Priority Review for Mercks Winrevair

FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Biologics

Vaccine Regulation Now a Political Process: Gottlieb

Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...