“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

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

The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...

Key Takeaways The U.S. Food and Drug Administration gave full approval to Moderna’s COVID shot for kids ages 6 months to 11 ...

A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.