The Latest Breaking News from the US Food and Drug Administration

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) moved closer to potential FDA approval for its Cardamyst (etripamil) nasal spray, an investigational therapy for paroxysmal supraventricular tachycardia (PSVT), as the U.S. Food and Drug Administration (FDA) accepted the company’s response to prior issues.

The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus.

The FDA has recalled 2 million Dexcom glucose monitors due to a serious safety risk. Learn how diabetic patients should act immediately to protect their health.

“If you want to take an experimental drug … you ought to be able to do that," said RFK Jr.

Reaching for the caffeine can backfire for some people

There is no safe level of exposure to lead for children, according to the U.S. Centers for Disease Control and Prevention

Discover the coin hack that checks whether your freezer is keeping your food safe.

Dr. Peter Marks criticized RFK Jr. for giving what he called "false hope" to families by claiming that the cause of autism will be identified by September.