The context-aware, multi-lingual AI agents act like a 24/7 digital FDA reviewer, helping MedTech companies improve ...

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...

COPENHAGEN, DENMARK / ACCESS Newswire / February 20, 2026 / FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, a ...

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for ...

A challenging public health policy landscape under health secretary Robert F. Kennedy has vaccine makers rethinking ...

Compass Pathways announced that its investigational psilocybin treatment has successfully met its primary endpoint in a Phase 3 trial in depression.

Corcept Therapeutics is upgraded to Buy after a patent loss and FDA setback, with focus shifting to relacorilant in oncology.

Truvian secured FDA clearance for its blood-testing device, but now at a critical point of development, they are without a CEO.

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...