Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and ...

Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

Learn more about lenacapavir, the most effective HIV treatment and prevention drug, and how its cost could cause a setback.

The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ genetic data to international labs. Based on “mounting evidence,” the FDA said ...

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...

A federal judge on Wednesday ruled that the Food and Drug Administration’s (FDA) decision to remove popular GLP-1s from its drug shortage list, ending the sale of compounded versions of the ...

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or ...

On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an ...