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Human Drugs

Recognify Reports Mixed Data on Schizophrenia Drug

Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated with schizophrenia, did...

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Human Drugs

Input Sought on Controversial Menopause Expert Panel

After being criticized for attempting to bypass a formal advisory committee review of warnings associated with hormone replacement therapies, FDA anno...

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Human Drugs

FDA Alert on Benzene Contamination in Products

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

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Medical Devices

Ethicon Endo-Surgery Recalls Echelon Vascular Stapler

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

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FDA General

Makary Defends CBERs Prasad After Loomer Attack

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

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Human Drugs

FDA Extends Review of Bayer Menopause Drug

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

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Human Drugs

FDA/ASCO Unite on Oncology Optimal Dosing

FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are potentially putting can...

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Human Drugs

Edwards Lifesciences Recalls Arterial Perfusion Devices

Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in whic...

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Human Drugs

Abivax Favorable Data in Ulcerative Colitis Trials

Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in modera...

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Marketing

Bill to Require Drug Price in DTC Ads

Five House members introduce a bill to require DTC television ads to include the drugs list price.