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

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

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

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

Food and Drug Administration officials plan to present data they claim links the Covid vaccine to 25 deaths in children at what’s expected to be a closely watched vaccine advisory committee next week, ...

“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 ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

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 ...

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 ...

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes ...