The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...

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

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

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

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

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

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Bread sold in a dozen states, including Ohio, has been recalled because the product may contain undeclared hazelnuts, ...

The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public health. The FDA was established when the Pure Food and Drugs Act was ...