FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

The FDA expedited drug review activity in December 2025 includes six fast-tracked therapies and the first National ...

The US Food and Drug Administration has missed its latest deadline to propose banning formaldehyde and certain formaldehyde-releasing chemicals from hair-straightening products, often used by Black ...

Johnson & Johnson MedTech announced today that it submitted its Ottava surgical robotic system to the FDA for de novo ...

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

The U.S. Food and Drug Administration has approved Myqorzo (aficamten) for the treatment of adults with symptomatic ...

Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, ...

Rakuten Medical has added to its tally of mega-rounds, pocketing another $100 million to push its lead light-based cancer ...