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FDA, Covid and vaccine approval

Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence

The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was not presented with detailed data.

· 20h · on MSN

FDA to tighten vaccine rules after memo ties COVID-19 shot to child deaths

· 9h · on MSN

FDA official plans to change vaccine approval process, claiming that Covid-19 shots caused child deaths

MedPage Today on MSN

Makary, RFK Jr. in Power Struggle; IHS Doctors Allege Censorship; Unusual FDA Vote

FDA chief Mary Makary, MD, MPH, and his boss HHS Secretary Robert F. Kennedy Jr. are locked in a power struggle over vaccine ...

JD Supra

Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and Likely Impact Are Unclear

On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in ...

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Senators urge HHS, FDA to reevaluate approval of a new generic version of mifepristone

A group of senators on Thursday urged Health Secretary Robert F. Kennedy Jr., and Food and Drug Administration Commissioner Marty Makary to reevaluate the approval of a new generic version of the ...

PharmExec

HHS Removes Misleading Safety Warning Information on Menopausal Hormone Therapy Label

Per the FDA's request, HHS is updating hormone therapy labels, removing misleading warnings to empower women in managing menopause and improving their health options.

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