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

FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, ...

In contrast, by utilizing technology-driven tools more effectively, we can drive efficiencies, improve communication, and ...

The IDE approval marks a pivotal milestone for Aqua Medical, allowing the company to begin enrolling patients in the U.S. RESTORE-1 pilot trial and study PIMA's potential to deliver durable metabolic ...

Seventeen healthcare organizations using Epic’s software are now connected to a federally backed health information network. The organizations began participating in the Trusted Exchange Framework and ...

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 ...