FDA

Coronavirus (COVID-19) Update: November 30, 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 issued…

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical…

FDA Approves New Imaging Drug to Help  Identify Ovarian Cancer Lesions

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is…

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and…

Coronavirus (COVID-19) Update: November 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: On Nov. 22, the…

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and…

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a…

FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

The following quote is attributed to Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for…

Coronavirus (COVID-19) Update: November 16, 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 Monday November 15,…

FDA In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to Spinach

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: Español “The FDA, along with the CDC and our…