FDA

Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

Today, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment…

FDA Roundup: September 6, 2022

September 6, 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 published the 2022:…

FDA Roundup: September 2, 2022

September 2, 2022

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

FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a…

Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize…

FDA Roundup: August 30, 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 published the FDA…

FDA Roundup: August 26, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:   Today, FDA provided additional guidance to…

FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

Today, the U.S. Food and Drug Administration announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected…

FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

Today, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and…

FDA Roundup: August 23, 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’s Office of Global…