Archive for February, 2021

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…

Coronavirus (COVID-19) Update: February 12, 2021

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

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow…

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to…

Coronavirus (COVID-19) Update: February 9, 2021

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

FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products

Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products,…

Coronavirus (COVID-19) Update: February 5, 2021

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