FDA approval. Many were added in secret, through a sneaky loophole built into the 1958 Food Additives Amendment.It was ...

The FDA has given some patients early access to the drug, daraxonrasib, as it nears regulatory approval. It's the first ...

Scientists found a key to Ozempic’s rise in Gila monster venom, leading to Byetta and the modern era of GLP-1 diabetes and ...

Emerging details follow a May 12 report affecting more than 17,000 bottles of a commonly prescribed blood pressure drug.

Beren Therapeutics is seeking approval in Neimann-Pick disease type C, an application the FDA was set to decide on by August 17. The new target action date is November 17.

As soon as this guidance came out, literally the same day, we started having conversations with our product team around what ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications ...

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, Food and Drug Administration Commissioner Marty Makary claimed Thursday — a bold accusation ...

A lot changed in the freezer aisle once food brands realized that shoppers don’t read the fine print. Cartons still showed ...