The U.S. Food and Drug Administration said on Friday it approved new labeling for Sarepta Therapeutics' gene therapy Elevidys ...

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...

(Reuters) -Trump administration officials, including Health Secretary Robert F. Kennedy Jr., have discussed scaling back the ...

The U.S. Food and Drug Administration can approve new personalized treatments for rare and deadly genetic diseases based on ...

The Food and Drug Administration inspected the food manufacturing facility of Fresh & Ready Foods LLC in San Fernando, CA, from March 31 to April 15, ...

Sarepta Therapeutics Inc.’s controversial gene therapy for a rare muscle condition will remain available in the US with a ...

Kennedy said hormone therapy could "reduce the risks of cardiovascular disease and mortality by as much as 50%, Alzheimer's ...

Hormone therapy drugs have carried box warning labels for years. Food and Drug Administration Commissioner Marty Makary talks ...

The FDA has issued warning letters to over a dozen companies selling 'unapproved' brands of Botox and warns consumers of the ...

According to an enforcement report from the Food and Drug Administration (FDA), Sun Pharmaceutical Industries Inc. initiated ...

Health Secretary Robert F. Kennedy Jr. considered installing a new leader to manage the agency on a day-to-day basis.