The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...

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 (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...

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

UniQure shares soared on positive AMT-130 Huntington's disease data, but plunged after the FDA reversed its stance on ...

The FDA denied approving DCA to treat a rare disorder called PDCD. The Higbees are urging the agency to reconsider.

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 ...

WASHINGTON (AP) — Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health Secretary Robert F. Kennedy Jr.’s team unrestricted access to a tightly ...

“Utilizing real-world data, technology, strategic solutions, and cross-departmental partnerships will help ensure equitable access, so the right member receives the right drug at the right time and ...

On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of its own artificial intelligence system, “Elsa.” The ...