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FDA asks mRNA vaccine makers to widen age range for rare heart risk warning

May 22, 2025
Pharmalot Columnist, Senior Writer
Lauren DeCicca/Getty Images

FDA asks mRNA vaccine makers to widen age range for rare heart risk warning

FDA asks Moderna and Pfizer-BioNTech to update warning labels on Covid-19 vaccines with expanded age range of men at risk for myocarditis.

By Elizabeth Cooney


Opinion: I'm a Republican former congressman and doctor. The new HHS placebo-controlled trial mandate is dangerous

Placebo-controlled trials for all new vaccines, even when a proven vaccine for a disease already exists, are a violation of basic medical ethics.

By Larry Bucshon


STAT+ | FDA chief pushes back on senators' criticism, says Covid booster trials should take 'roughly a year'

Makary told senators that staffing cuts haven't hindered the FDA's main missions.

By Lizzy Lawrence



Uncertainty in CRISPR world and the start of more M&A

STAT reporters chat about the mood in the gene editing field, M&A deals in biotech, and leadership changes at Novo Nordisk.

By Allison DeAngelis, Elaine Chen, and Adam Feuerstein


STAT+ | Biotech investor activism is on the rise

Investors should have more say in how their money is spent. Too often, management teams take a dismissive "we know better" attitude

By Adam Feuerstein


Opinion: The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines

Two people with limited expertise in vaccinology — Vinay Prasad and Marty Makary — are leading the FDA vaccine evaluation process.

By Kathryn M. Edwards


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