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Makary Defends CBERs Prasad After Loomer Attack

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FDA commissioner Marty Makary defends CBER director Vinay Prasad from recent criticism by Trump confidant Laura Loomer.

FDA Extends Review of Bayer Menopause Drug

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FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for tr...

FDA/ASCO Unite on Oncology Optimal Dosing

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FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are pot...

Edwards Lifesciences Recalls Arterial Perfusion Devices

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Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after recei...

FDA Alert on Benzene Contamination in Products

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FDA issues an alert based on related to its ongoing investigation into the root causes of benzene contamination, calling on drug m...

Ethicon Endo-Surgery Recalls Echelon Vascular Stapler

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Ethicon Endo-Surgery recalls (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the products inadver...

Medline Recalls Craniotomy Kits

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Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable P...

FDA Priority Review for Sprouts Addyi sNDA

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FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal wo...

FDA to Demand New Elevidys Safety Data from Sarepta

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FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the com...

Abivax Favorable Data in Ulcerative Colitis Trials

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Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimo...