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CGMP Violations at Exela Pharma Sciences

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

Support for Biosimilar Legislation

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

FDA Prodded to Improve Surrogate Endpoint Transparency

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

Taiho Reports Unfavorable DMD Drug Data

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

FDA Urged to Expand Real-World Data Use

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

Multiple Insightra Medical Violations Cited

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

FDA Study Finds Liver Risks Associated with CBD

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A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concern...

Expanded Parkinsons Use OKd for Insightec Device

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FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatme...

FDA Oxylanthanum Carbonate Complete Response Letter

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FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites i...

FDA Accelerated Approval for Dizal Zegfrovy

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FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.