Close

FDA

FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld

FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. Detailed neutralization data can be found in […]

Read More

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 bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which […]

Read More

First Nonprescription COVID-19 Test That Also Detects Flu and RSV

The FDA has authorized the first nonprescription diagnostic test that can identify multiple viruses that cause COVID-19–like respiratory symptoms, including respiratory syncytial virus (RSV). FDA officials see it as another step toward diagnostic testing at home for certain viruses. In addition to SARS-CoV-2 and RSV, the Labcorp Seasonal Respiratory Virus […]

Read More

Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

On Tuesday, the U.S. Food and Drug Administration’s independent experts on the Vaccines and Related Biological Products Advisory Committee met to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. The COVID-19 vaccines […]

Read More

FDA: Moderna Vaccine Safe for Kids 6 Months to 17 Years

U.S. Food and Drug Administration advisers say Moderna’s COVID-19 vaccine is safe and effective for children aged 6 months to 17 years, according to an FDA document made public on Friday. Two doses of the Moderna vaccine caused an immune response in clinical trial participants that was similar to the immune response […]

Read More

La FDA aprueba la primera dosis de recuerdo para los de 5 a 11 años

Con fecha 17 de mayo, la Food and Drug Administration de los Estados Unidos (FDA) ha concedido la autorizado de uso en emergencias de la vacuna Comirnaty en niños de cinco a once años, siempre que hayan transcurrido al menos cinco meses desde la recepción de las dosis de primovacunación con la […]

Read More

FDA Authorizes COVID Booster for Younger Kids

A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday. The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency […]

Read More

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: Hospitalized, or Not hospitalized and have […]

Read More
Translate »