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Some records contain detailed evidence; others currently contain only basic identity and regulatory information. Reviewed conclusions appear only when they are available for a specific use and group of people.
Showing 1–2 of 2 records
Resmetirom (Rezdiffra)
Small chemical medicineFDA accelerated approval (based on an earlier result expected to predict benefit; follow-up evidence may be required)Detailed recordUse listed on the medicine record
Fatty liver disease with inflammation and moderate to advanced scarring
Pemivibart (Pemgarda)
Small chemical medicineFDA accelerated approval (based on an earlier result expected to predict benefit; follow-up evidence may be required)Expanded recordUse listed on the medicine record
EMERGENCY USE AUTHORIZATION FOR PEMGARDA The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA (pemivibart) for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg): Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive…