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An unusual FDA panel on antidepressant use during pregnancy elevated skeptics of the drugs 

July 25, 2025
Pharmalot Columnist, Senior Writer
Adobe

STAT+ | An unusual FDA panel on antidepressant use during pregnancy elevated skeptics of the drugs

Makary is recruiting researchers to weigh in on hormone therapy and SSRIs. The panels seem to have a bias, and the FDA's goal is unclear.

By Lizzy Lawrence


STAT+ | Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

Regulatory decisions elsewhere mean the Sarepta drug, Elevidys, is not being shipped anywhere worldwide.

By Andrew Joseph


Opinion: Plans to test prior authorization in traditional Medicare are deeply troubling

WISeR, a Medicare demonstration program from the CMS Innovation Center, will not cut waste — but it will hurt seniors.

By Donald M. Berwick and Andrea Ducas



Courtesy Eli Lilly

STAT+ | European regulators endorse Lilly's Alzheimer's treatment for certain patients

Regulators had initially said the drug should be rejected, but issued a limited approval recommendation following an appeal.

By Andrew Joseph


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Correction: Yesterday's newsletter had an outdated subject line. We regret the error. Happy Friday.

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