Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...

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

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

The FDA's planned rollback of oversight shifts risk onto patients and clinicians ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...