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

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 ...

The FDA has approved a new sunscreen ingredient called bemotrizinol for use in the United States, marking the first time in ...

This is part one of a two-part article offering proposals to improve the FDA’s guidance to implement a new approval framework ...

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 ...

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 ...

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 ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

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 Food and Drug Administration (FDA) this week approved the first new sunscreen filter in more than two decades, sparking ...

Shares of Outlook Therapeutics OTLK rallied 35.3% on Tuesday after the company announced that the FDA accepted the ...