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FDA to lower number of trials required for drug approvals

December 4, 2025
Pharmalot Columnist, Senior Writer
FDA Commissioner Martin Makary
Evan Vucci/AP

STAT+ | FDA to lower number of trials required for approval of drugs, other medical products

FDA is moving to require one clinical study, not the standard two, for medical products before consideration for approval, commissioner says.

By Lizzy Lawrence


STAT+ | Tracy Beth Høeg, Makary aide who investigated Covid vaccines, to lead FDA drug center

Høeg will be the fifth person to lead the center this year, and her appointment comes after Richard Pazdur's abrupt retirement.

By Lizzy Lawrence and Chelsea Cirruzzo


STAT+ | Vinay Prasad, FDA's vaccine regulator, waves off criticism in closed-door remarks

Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.

By Damian Garde and Lizzy Lawrence



Molly Ferguson/STAT

STAT+ | What to expect at the ASH meeting, and some thoughts on the FDA's Richard Pazdur

In this week's edition of "Adam's Biotech Scorecard," Adam addresses the latest FDA twist and gets ready for the American Society of Hematology meeting.

By Adam Feuerstein


STAT+ | Paradigm Health, seeking to use AI to enroll clinical trials, partners with Roche

The AI startup announced it has raised another round of funding and is acquiring a business from Flatiron Health.

By Matthew Herper


CDC vaccine advisers appear likely to recommend delaying hepatitis B vaccine birth dose

CDC vaccine panel appears prepared to recommend scrapping universal hepatitis B birth dose, a shift experts warn could trigger a surge in chronic infections in children.

By Helen Branswell, Daniel Payne, and Chelsea Cirruzzo


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