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 ...

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 ...

The trouble with FDA's move to require only one study for new drugs ...

A randomized controlled study found that time-restricted feeding—a form of intermittent fasting—significantly reduced ...

Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment 75% of soquelitinib patients achieved EASI 75, 25% ...

The emergence of AI and biosensors offers a chance to address inefficiencies in drug development.