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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 (OTC)…

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 human body temperature—also…

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 articles of…

Coronavirus (COVID-19) Update: March 2, 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 agency has updated…

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 can help facilitate transvaginal…

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 antigen test where certain…

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 disease 2019 (COVID-19)…

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 Administration has informed the sponsor that…

Coronavirus (COVID-19) Update: February 26, 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 held…

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 Deficiency Type A,…