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FDA General

CDC, NIH Staff Protest Trump Administration Chaos

Current and former CDC employees rally outside the agencys Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the healt...

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Human Drugs

Amish Origins Marketing Unapproved Drugs: FDA

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

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Human Drugs

FY 2024 Real-World Evidence Statistics Out

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

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Human Drugs

Bayesian Demo Project Explained

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

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Human Drugs

Government Drug Price Listening Sessions

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

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Human Drugs

AbbVie Gains Expanded Label on Hep C Drug

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

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Human Drugs

Nuvation Lung Cancer Drug Ibtrozi Approved

FDA approves a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small...

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Human Drugs

FDA to Tweak Industry/Reviewer Communications: Makary

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

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Human Drugs

FDA Grants, Denies Fenofribrate Petition

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

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Human Drugs

FDA Puts Hold on Gilead HIV Trials

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