Jan 19 () - Pharmaceutical company Boehringer Ingelheim said on Monday the U. Food and Drug ​Administration had approved its ...

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the ...

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged sword." ...

The Food and Drug Administration has identified more cookware that could be leaching lead into your food, it said in an expanded warning updated on Nov. 24. Since October, nine more products have been ...

Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe ...

In a series of high-impact moves, the FDA is reshaping how it approves and regulates drugs, including accelerating reviews, revising vaccine standards and simplifying biosimilar development.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...

The U.S. Food and Drug Administration approved Fortress Biotech and Indian ‍drugmaker Zydus Lifesciences' drug for a type of ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...