Senators cite study showing 22 times higher serious side effects from chemical abortion drugs than FDA labels indicate, ...

In any review of mifepristone, the FDA will now have to grapple with Judge Otake’s conclusion that the 2023 REMS decision for ...

The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left ...

The U.S. Food and Drug Administration will review evidence about the safety and efficacy of mifepristone, one of the drugs used in medication abortion, to investigate how it can be safely dispensed, U ...

The U.S. Food and Drug Administration is changing its policy on who should get COVID-19 shots, potentially limiting access to new vaccine formulations as they enter the market. New and updated jabs ...

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, was no more effective than a placebo, a Reuters review of agency ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...