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

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

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 ...

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

The participants in the trial – similar to two-thirds of breast cancer patients overall - had tumors that use the hormones estrogen and progesterone to grow. The goal of so-called endocrine therapy is ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

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

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

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

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

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

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...