FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

Another Breakthrough Summit West in the books, and what an excellent event! We kicked off the day with former FDA head Robert ...

An FDA advisory committee is scheduled to meet to discuss the formula for the next COVID-19 vaccines after being sidelined ...

As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that ...

New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had ...

"You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA ...

A combination shot for flu and Covid-19 using messenger RNA generated antibodies in a study, but US government regulators ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...