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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...

FDA Misses Review Decision on Stealth Bio NDA

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FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondri...

Amazon Selling Unapproved, Misbranded Drugs: FDA

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FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic proc...

CGMP Issues at BEO Pharmaceuticals

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FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.