Archive for February, 2021

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,…

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…

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 transported and stored…

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 (DMD) in patients who…

Coronavirus (COVID-19) Update: February 23, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Yesterday, the FDA issued…

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 therapeutics products, to address the emergence and…

Coronavirus (COVID-19) Update: February 19, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Feb. 16, the…