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.

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Nov 23, 2020, 20:49 ET FDA Approves First Drug to Treat Rare Metabolic Disorder

Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare...


Nov 23, 2020, 12:41 ET FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...


Nov 21, 2020, 20:17 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 casirivimab and imdevimab to be administered together...


Nov 20, 2020, 17:47 ET FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria...


Nov 20, 2020, 17:17 ET Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10...


Nov 19, 2020, 17:54 ET Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir,...


Nov 18, 2020, 17:44 ET Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba de COVID-19 para autodiagnosticarse en el hogar

Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) emitió una autorización de uso de emergencia (EUA)...


Nov 17, 2020, 22:30 ET Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at...


Nov 17, 2020, 10:00 ET La inocuidad alimentaria puede ser vital para las personas con diabetes

¿Sabía usted que noviembre es el Mes Nacional de la Diabetes? La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) le recuerda a ...


Nov 17, 2020, 10:00 ET Food Safety Can Be Crucial for People With Diabetes

Did you know November is National Diabetes Month? The U.S. Food and Drug Administration (FDA) reminds people with diabetes (and those preparing food...


Nov 16, 2020, 13:59 ET FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based...


Nov 10, 2020, 20:25 ET FDA In Brief: FDA Announces Investigation of a Third Outbreak of E. coli O157:H7

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: "The FDA is investigating a third outbreak...


Nov 10, 2020, 11:22 ET FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels

The U.S. Food and Drug Administration today issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient...


Nov 09, 2020, 19:00 ET Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy...


Nov 06, 2020, 19:15 ET FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

Today, the U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to ...


Nov 06, 2020, 18:21 ET Actualización sobre el coronavirus: La FDA autoriza la primera prueba que detecta anticuerpos neutralizantes de una infección reciente o anterior de SARS-CoV-2

Hoy, la Administración de Alimentos y Medicamentos de los EE. UU (FDA, por sus siglas en inglés) autorizó la primera prueba de serología que detecta...


Nov 06, 2020, 15:01 ET Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2...


Nov 06, 2020, 10:58 ET FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance

Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration's drug compounding...


Oct 30, 2020, 18:38 ET FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities

This week, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs...


Oct 30, 2020, 09:14 ET FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next...


Oct 28, 2020, 15:43 ET FDA In Brief: FDA Announces Investigations of Two Outbreaks of E. coli O157:H7 Illnesses

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: "The FDA, along with the CDC and our state...


Oct 27, 2020, 15:41 ET FDA Approves Lotion for Nonprescription Use to Treat Head Lice

Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a...


Oct 27, 2020, 10:00 ET No olvidemos la importancia de la inocuidad alimentaria: consejos de la FDA

A medida que el clima se va enfriando, quizás desee pasar más tiempo horneando o guisando en su cocina, o tomando una copa de sidra. ¿Qué mejor forma ...


Oct 27, 2020, 10:00 ET We're Falling for Food Safety: Tips From FDA

As the weather gets cooler, you may find yourself wanting to spend more time baking or cooking in your kitchen or sipping a cup of cider. What better ...


Oct 22, 2020, 17:10 ET FDA Approves First Treatment for COVID-19

Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age ...