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FDA Takes Actions to Expand Use of Treatment for Outpatients With Mild-to-Moderate COVID-19

Claudia Baldwin

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The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.

Source: fda.gov

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FDA Approves Neoadjuvant Nivolumab and Platinum-doublet Chemotherapy for Early-stage Non-small Cell Lung Cancer

Claudia Baldwin

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FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

Original Article: fda.gov

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First Generic Drug Approvals

Claudia Baldwin

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Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients. “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.

Original Article: fda.gov

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FDA Issues Series of Guidances Under Drug Competition Action Plan

Claudia Baldwin

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CDER Statement

Original Source: fda.gov

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