Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...

The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments ...

As states wrap up legislative sessions, now is the time to reflect on the victories from the year and the lessons to be taken ...

This completion is a crucial requirement in the approval process for a drug.

Allurion Technologies (ALUR) announced it has passed critical milestones in the FDA pre-market approval process for the Allurion Smart Capsule. In ...

Clinical data must be strong enough to exclude regression to the mean.

The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...

Amazon is under scrutiny for its absence policy affecting disabled employees, as the FDA simplifies approval for personalized ...

Investing.com -- Allurion Technologies Inc. (NYSE:ALUR) stock surged 10.9% in Tuesday’s premarket trading after the weight loss technology company announced significant progress in its FDA approval ...

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...