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 firm is now offering combined ex vivo drug sensitivity and genomic testing to cancer patients outside the clinical trial setting.

Vancouver, Canada, November 4th, 2025, FinanceWire USA News Group News Commentary – Healthcare’s embrace of AI is moving from pilot to ...

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

The FDA is expected to decide on treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone ...

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

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 ...

The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to interpret ...

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

The US Food and Drug Administration said Friday that it is taking action to restrict the use of prescription fluoride supplements, following a directive from the government’s Make American Healthy ...

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

FDA issues new guidance aimed at speeding biosimilar time to market and lower costs, and more in the latest National Advocacy ...