Breakthrough study finds single dose of psychedelics significantly reduced depression symptoms in clinical trial, with effects lasting up to six months.

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...

MORRISVILLE, NC / ACCESS Newswire / February 12, 2026 / Clinical trials are the research studies required to test the ...

In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials.

AI promised to speed up drug discovery, but the real bottleneck is in clinical trials. This startup is using AI to accelerate ...

NIH updates clinical trial definition to exclude basic experimental studies involving humans from clinical trial requirements starting May 2026.

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...

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 ...

Teva Pharmaceutical Industries Limited TEVA shares are higher during Tuesday’s premarket session as the company is discussing ...

Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency on June 26 issued a new outline of its proposed requirements for the racial and ethnic ...

There's an unsung success story about the first year of the COVID-19 pandemic. At its outset, U.S. hospitals faced huge challenges, as influxes of patients strained resources, while doctors were ...

The patient, who is in his 30s, got the one-time intravenous infusion at the Infusion and Chemotherapy Treatment Center at Henry Ford Cancer-Detroit.