On December 11, 2020, FDA authorized the first EUA (Emergency Use of Authorization) for a vaccine for COVID-19) for individuals 16 years...

There is an outbreak of respiratory disease caused by a novel coronavirus called “Coronavirus Disease 2019” (COVID-19) and it raised...

The Food and Drug Administration has authorized emergency use of the first at-home coronavirus test, which gives results back in about 30...

On Monday Pfizer announced that its coronavirus vaccine developed with BioNTech SE prevented 90 % of infections in a trial with tens of...

Photo Courtesy of Nikki Teixeira, by Katie Kindelan, ABC News Last September, a mom in Canada was warning parents and caregivers after...

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and...

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and...

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee...

On August 28, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing...

FDA medical device user fees of both standard rates and small-business rates will slightly increase for 2021 fiscal year, which is...