News

FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts

Today, the U.S. Food and Drug Administration authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years…

Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored…

FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation

Today, the U.S. Food and Drug Administration granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who…

Coronavirus (COVID-19) Update: February 23, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Yesterday, the FDA issued…

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and…

Coronavirus (COVID-19) Update: February 19, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Feb. 16, the…

FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders

Today, the U.S. Food and Drug Administration announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or…

COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging

After more than a year since the coronavirus disease 2019 (COVID-19) outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S….

FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device

Today, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is…

Coronavirus (COVID-19) Update: February 16, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…