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AbbVie Gains Expanded Label on Hep C Drug

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FDA approves an AbbVie expanded label for Mavyret (glecaprevir/pibrentasvir) to include treating adults and pediatric patients thr...

Nuvation Lung Cancer Drug Ibtrozi Approved

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FDA approves a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS...

FDA to Tweak Industry/Reviewer Communications: Makary

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FDA commissioner Marty Makary says the agency will improve the communication channels between reviewers and companies to help spee...

FDA Grants, Denies Fenofribrate Petition

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FDA says it has made labeling changes to fenofibrates as requested in a Healthy Women petition and does not see a need for additio...

FDA Puts Hold on Gilead HIV Trials

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Based on safety concerns, FDA places a clinical hold on Gileads HIV treatment trials of GS-1720, an investigational integrase stra...

OPDP Finds False, Misleading Addyi Post

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The CDER Office of Prescription Drug Promotion warns Sprout Pharmaceuticals about a social media post for its Addyi that does not ...

Contaminated Zicam and Orajel Lots Recalled

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Due to contamination concerns, Church & Dwight recalls all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and ...

No IND for American Behavioral Study: FDA

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FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium...

More Comprehensive AI Regulation Needed: Report

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U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.

Makary/Prasad Priorities for A New FDA

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FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call ...