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

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

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

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

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...

The Food and Drug Administration (FDA) has issued a new guidance document entitled “Enhancing Participation in Clinical Trials – Eligibility Criteria, Enrollment Practices, and Trial Decision.” The ...

PharmaEssentia Announces Updated NCCN Clinical Practice Guidelines Include ropeginterferon alfa-2b-njft (BESREMi®) for ...