Caliway intends to commence both pivotal Phase III trials soon, with clinical results for CBL-0301 and CBL-0302 expected in ...

While drugs such as Wegovy target a single gut hormone, retatrutide is among a new class of GLP-1 drugs that aims at three hormone receptors ...

The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder.

Metformin costs about five cents a pill. More than 150 million people worldwide swallow it every day to manage type 2 ...

Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process. Historically, trials have required tedious tabulations and repeated ...

Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of phase one clinical trials and applications to the FDA at the end of the ...

The results bring Lilly one step closer to filing for approval of the injection, retatrutide, which works differently from ...

On February 18, 2026, U.S. Food and Drug Administration (FDA) Commissioner Martin Makary and the outgoing director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad published an ...

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce “20, 30, 40% of overall clinical trial time,” according to FDA Chief ...

The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development. But statisticians and researchers are divided on ...

The FDA has released new draft guidance outlining the use of Bayesian methodologies in clinical trials for drugs and biologics. The guidance is intended to help sponsors apply modern statistical ...