After Reviewing Historical Use and Modern Safety Evidence, Officially Confirms Kava is a Food Under Federal Law LOS ANGELES, ...

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

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

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

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

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

The US Food and Drug Administration has missed its latest deadline to propose banning formaldehyde and certain ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for tech companies and investors.

In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer ...

PHILADELPHIA, January 07, 2026--iECURE Receives FDA Regenerative Medicine Advanced Therapy Designation for ECUR-506 for ...

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

The Naox Link in-ear EEG platform is the first of its kind to be cleared for prescription use at home or in healthcare ...