Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday ...

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug ...

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...

The US Food and Drug Administration (FDA) and representatives from industry have reached an agreement in principle on ...

Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal ...

AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to ...

Michigan's 340B Drug Pricing Program, meant to help vulnerable patients, is being misused by hospitals, impacting care access ...

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...

DOJ moves medical cannabis to Schedule III; biotech firms eye funding and IPOs amid banking and tax uncertainty.

In a landmark week for medical innovation, the FDA approved or cleared multiple breakthrough technologies, from the first gene therapy for genetic hearing loss to a wireless brain implant trial for ...

Participation in state AIDS Drug Assistance Programs was associated with improved HIV treatment outcomes and high rates of viral suppression.