Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...

The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...

Employees of the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and ...

British animal genetics company Genus on Wednesday said the U.S. Food and Drug Administration (FDA) approved its PRP gene ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...

The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...

Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...

The Supreme Court’s recent reversal of the Chevron doctrine means every new regulation is now living on borrowed time — and ...