Capricor’s BLA for Deramiocel was granted Priority Review in March 2025 and was supported by data from the HOPE-2 trial, its open-label extension (OLE), and natural history comparisons from FDA-funded ...

She’s on the show to talk about why the cuts at the FDA have some experts concerned, how intertwined the U.S. and Canadian food systems are, and why it’s so challenging to disentangle them.

Delaware food establishment inspection reports Which food establishments had the most violations during 30-day periods? Click on the links below to find out.

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a ...

Texas will put warning labels on some foods, but its additives list has inaccuracies Texas would be the first in the U.S. to use warning labels to target additives, rather than nutrients like ...

A new Texas law requires warning labels on foods with additives banned elsewhere. This impacts the food industry and may lead to legal challenges.

A Texas law promoting the “Make America Healthy Again” agenda requires first-ever warning labels on foods like chips and candies. It also mispresents the status of some of the ingredients.

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

The U.S. Food and Drug Administration has proposed front-of-package labels that would flag levels of saturated fat, sugar and sodium.

For example, the food additive azodicarbonamide, known as ADA and used as a bleaching agent in cereal flours, is included on the Texas list.