The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

MARYLAND HEIGHTS — The drug manufacturer Sentio BioSciences has announced a major $10.6 million expansion the company says ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

Curay, the top FDA drug regulator, acknowledged that much is still in flux at the agency and introduced a new deputy.

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical drugs reach the public and significantly cut down the time in ...

The Food and Drug Administration is scrambling to hire contractors to replace fired employees who helped plan thousands of food and drug safety inspections throughout the world.

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes acrimonious questions from Senators about agency staffing cuts, limits on COVID ...

FDA job cuts hinder drug safety monitoring Pharmacists say some safeguard programs for risky medications have stopped, basic information about others is unavailable ...

The FDA recently delayed a PDUFA date for NovaVax’s COVID-19 vaccine without citing a reason. NovaVax is seeking full approval for the vaccine, which is the only non-mRNA option available in the ...

The Food and Drug Administration is scrambling to hire contractors to replace fired employees who ... There is no official tally of jobs lost at FDA and many supervisors still don't how many of ...