FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules ...

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 ...

A new report estimates speeding up FDA drug approvals by one year could generate over $10 trillion in economic value from ...

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 ...

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

The FDA could approve the first blood test that can detect multiple cancers, around the end of the year, setting the stage ...

Peptides are everywhere — promising to fix wrinkles, weight gain, and even torn ligaments. But are they safe? The FDA is ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.