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Amish Origins Marketing Unapproved Drugs: FDA

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FDA warns Worland, WY-based Amish Origins Management about CGMP violations in its manufacturing of unapproved and misbranded drug ...

FY 2024 Real-World Evidence Statistics Out

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FDA publishes statistics on real-world evidence submissions to CBER and CDER in FY 2024 compared to the previous year.

Bayesian Demo Project Explained

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FDA posts an online notice explaining CDERs Bayesian Statistical Analysis demonstration project.

Government Drug Price Listening Sessions

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The Federal Trade Commission and Justice Department announce three live-streamed listening sessions on aspects of the effort to cu...

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 ...