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Makary Suggests Raising Bar on Covid Boosters

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FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

Little Trust in New Health Leaders: Poll

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A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public he...

FDA Layoffs Affect Product Development: Post

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Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.

FDA OKs J&Js Imaavy for Myasthenia Gravis

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FDA approves a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis.

Unanimous SCOTUS Decision Reassuring: Post

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George Washington University law professor Richard Pierce praises a recent unanimous Supreme Court decision backing FDA in an e-ci...

Boehringer Drug Shows Encouraging Data in Lung Cancer

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Boehringer Ingelheim releases new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthro...

No Broad FDA Reorganization Coming: Makary

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In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at...

Senator Hawley Urges FDA Action on Mifepristone Study

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Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly revealing greater safety risks tha...

Cosco International CGMP Inspection Findings

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FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.

Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

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A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deduct...