News from u.s. food and drug administration A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle.

Latest

Mar 05, 2021, 18:28 ET Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive...

Mar 05, 2021, 15:13 ET Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter...

Mar 04, 2021, 20:42 ET FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale

The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure...

Mar 04, 2021, 14:52 ET Semana Nacional de Protección al Consumidor: La FDA se mantiene alerta para proteger a los consumidores de las estafas relacionadas con las vacunas contra el COVID-19

Se ha dicho que hay buena pesca en aguas turbulentas y ése ha sido el caso de los estafadores que buscan beneficiarse de la ansiedad y los temores...

Mar 04, 2021, 12:18 ET Federal judge enters permanent injunction against New York-based dietary supplement manufacturer

A dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any...

Mar 01, 2021, 09:58 ET FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that ...

Mar 01, 2021, 09:24 ET Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another...

Feb 27, 2021, 18:41 ET FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus...

Feb 26, 2021, 18:50 ET FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug...

Feb 26, 2021, 18:10 ET FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A

Today, the U.S. Food and Drug Administration approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor...

Feb 26, 2021, 11:53 ET 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 and...

Feb 25, 2021, 16:28 ET 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...

Feb 25, 2021, 14:37 ET 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...

Feb 23, 2021, 10:18 ET Utilice la etiqueta de información nutricional para elegir opciones alimentarias buenas para el corazón

¿Sabía que febrero es el Mes Nacional del Corazón en los Estados Unidos? Según los Centros para el Control y la Prevención de Enfermedades (CDC, por...

Feb 22, 2021, 12:37 ET 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...

Feb 19, 2021, 16:53 ET 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,...

Feb 19, 2021, 16:04 ET Actualización sobre el COVID-19: El USDA y la FDA enfatizan que la información epidemiológica y científica actual indica que no hay transmisión del COVID-19 a través de los alimentos o de los envases de los alimentos

Después de más de un año de que el brote de la enfermedad por coronavirus 2019 (COVID-19) fuera declarado una emergencia de salud mundial, el...

Feb 18, 2021, 13:24 ET 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...

Feb 17, 2021, 14:42 ET 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...

Feb 16, 2021, 10:00 ET Use the Nutrition Facts Label to Make Heart-Healthy Food Choices

Did you know that February is American Heart Month? According to the Centers for Disease Control and Prevention (CDC), heart disease is the leading...

Feb 12, 2021, 17:15 ET 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...

Feb 09, 2021, 20:16 ET 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...

Feb 08, 2021, 13:27 ET FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products

The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine: Veterinary regenerative ...

Feb 05, 2021, 15:01 ET FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with...

Feb 05, 2021, 12:52 ET FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive...