Archive for February 26, 2021

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,…

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…