Investigation Reveals Deep Flaws in FDA Drug Approval Process, Raising Concerns Over Public Safety** A recent investigative report has uncovered alarming findings regarding the ...

Ultragenyx Pharmaceuticals took another hit when the FDA rejected its gene therapy for patients with a rare, genetic disorder.

In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...

How nicotine pouches are causing a rise in poisoning cases among young children and what parents can do to prevent it ...

Zimmer Biomet Holdings Inc. and Monogram Technologies Inc., an orthopedic robotics company, have announced that they have ...

Johnson & Johnson MedTech (NYSE: JNJ) today announced FDA approval for an update to its Varipulse platform's irrigation flow ...

The FDA published over 200 response letters sent as replies to drug and biological product applications in order to increase transparency.

Meanwhile, Bloomberg reports that the FDA may offer to fast-track drug reviews for companies that lower their U.S drug prices. Also: a billion-dollar backlog of delayed grants at HHS, and more.

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH), hosted a workshop ...

Corcept Therapeutics has filed for U.S. Food and Drug Administration approval of its relacorilant drug candidate for the treatment of patients with platinum-resistant ovarian cancer.

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

Finerenone gained FDA approval for heart failure treatment, showcasing significant benefits in reducing cardiovascular events ...