FDA

Antibodies discovered at Vanderbilt for prevention of COVID-19 granted FDA emergency use authorization

The U.S. Food and Drug Administration granted emergency use authorization (EUA) to the global biopharmaceutical company AstraZeneca for a long-acting antibody combination which  protects against COVID-19, discovered last year at Vanderbilt University Medical Center.

U.S. government reserves supply of COVID-19 antibody cocktail discovered at VUMC

The U.S. government has reserved up to 700,000 doses of a monoclonal antibody cocktail against the COVID-19 virus discovered at Vanderbilt University Medical Center and developed by AstraZeneca, officials have announced.

COVID treatment studied by VUMC gains FDA approval

Researchers at Vanderbilt University Medical Center played a key role in the development of remdesivir, the first drug approved by the U.S. Food and Drug Administration for the treatment of COVID-19.

Zantac recalled for carcinogen levels above FDA standards

The popular heartburn drug ranitidine, commonly known as Zantac, was voluntarily recalled due to the contamination of a human carcinogen that could potentially cause cancer. The recall includes oral tablets, capsules, and syrup.

VUMC assumes new role in FDA safety monitoring

Vanderbilt University Medical Center is assuming an expanded role in U.S. Food and Drug Administration (FDA) medical product safety monitoring.

Treatment approved for patients with acute graft-versus-host disease

The U.S. Food and Drug Administration (FDA) recently approved ruxolitinib, the first drug for patients with acute graft-versus-host disease (GVHD) who have an inadequate response to steroid treatment. VUMC’s Madan Jagasia, MBBS, MS, MMHC, was a lead investigator of the REACH1 trial that was the basis for the FDA approval.

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