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Trump Officials Blocked Psychedelic Drug from Voucher Program

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Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from b...

Funding Bill Reinstates FDA Pediatric Drug Voucher Program

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President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher pr...

Amgen Dismisses FDA Request to Withdraw Tavneos

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Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to ...

Datroway sBLA for Triple-Negative Breast Cancer Under Review

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FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as ...

Former FDA LASIK Official Morris Waxler Dies at 88

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Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a promine...

FDAs Expanding Role, Staff Cuts Challenge Oversight: GAO

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A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it face...

FDA Issues Complete Response on Subcutaneous Saphnelo

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FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous formulation of Saphnelo (anifrol...

QS, MDR Violations at Mexicos Unomedical Device

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FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infu...

Abbott Diabetes Care QS Violations

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FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Al...

Repeat CGMP Violations at Kirkman Drug Manufacturing

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FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished...