Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance ...

Several food items sold in vending machines throughout Ohio, northern Kentucky, and eastern Indiana are being recalled due to an undeclared Sesame allergen, according to the U.S. Food and Drug ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy for a type of muscle disorder.

Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Two Indian brothers received 30 months in prison for selling counterfeit drugs to U.S. patients, endangering lives across the country.