Istituzioni

FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.

The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season.

FDA approved Rukobia (fostemsavir), a new antiretroviral medication for adult patients with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.

Coronavirus (COVID-19) Update: Daily Roundup

FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products.

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

The FDA is taking important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines.

Coronavirus (COVID-19) Update: Daily Roundup

FDA approves Keytruda for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

FDA approves Phesgo to treat adult patients with HER2-positive breast cancer. Phesgo can be administered at home by a health care professional once chemotherapy is finished.

Coronavirus (COVID-19) Update: Daily Roundup

FDA approves Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19.

Coronavirus (COVID-19) Update: Daily Roundup

FDA launches Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup