FDA

FDA Approves Treatment for Wider Range of Patients with Heart Failure

Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance…

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

Today, the U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs)…

FDA Roundup: February 22, 2022

February 22, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a new resource,…

FDA Roundup: February 18, 2022

February 18, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA is announcing that it…

FDA Roundup: February 11, 2022

February 11, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Feb. 11, the U.S. Food and…

Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains…

Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the…

FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management

Today, the U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and…

FDA Roundup: February 4, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Feb. 3, the FDA issued a…

FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School Meals

One of the U.S. Food and Drug Administration’s top priorities is to improve the health of Americans through better nutrition. We are pleased to see…