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F.D.A. Seeks More Oversight of Vaccine Trials and Approvals

The agency’s top vaccine regulator proposed broad changes, claiming that a new review linked 10 children’s deaths to the Covid vaccine. But public health experts questioned the findings, wanting to examine the data.

Β© Hannah Beier for The New York Times

Dr. Vinay Prasad, the F.D.A.’s top vaccine official, suggested in a memo that the deaths were related to vaccine-related myocarditis but did not offer data to support his conclusions.
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F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths

A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.

Β© Brian Snyder/Reuters

The drug Elevidys has been central to the business model of Sarepta Therapeutics, a publicly traded company that is worth about $2 billion.
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Infant Formula Company Tied to Botulism Outbreak Had Known Problems

A Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

Β© Eugene Gologursky/Getty Images

Ron Belldegrun and Mia Funt, the two founders of ByHeart, during a ribbon-cutting at plant in Reading, Pa., in 2022.
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F.D.A. Names Agency Veteran to Run Drug Division

Dr. Richard Pazdur, who has been the F.D.A.’s top cancer drug regulator, represents a stabilizing choice for an agency reeling under staff cuts and low morale.

Β© Andrew Mangum for The New York Times

Dr. Richard Pazdur will now lead the Center for Drug Evaluation and Research, which is in charge of regulating most prescription drugs and over-the-counter medicines.
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Big Food’s Fight Against Kennedy Is Heating Up

A new industry group wants to set aside the piecemeal state-by-state approach imposing food dye and labeling laws in favor of federal control. The opposition has roiled the MAHA coalition.

Β© Tierney L. Cross/The New York Times

Robert F. Kennedy Jr., secretary of Health and Human Services, faces emerging foes in the food industry that are challenging his Make America Healthy Again agenda.
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