Tag: Food & Drug Administration
First Drug Approved to Treat Rare Metabolic Disorder
Oxlumo granted approval to treat primary hyperoxaluria type 1
FDA Authorizes Use of Monoclonal Antibody Treatment for COVID-19
IV infusion of casirivimab and imdevimab authorized for treatment of mild-to-moderate COVID-19
FDA Issues EUA to Baricitinib Plus Remdesivir for COVID-19
Emergency use authorization applies to hospitalized patients requiring supplemental oxygen, mechanical ventilation, ECMO
Antibody Treatment Approved for Emergency Use Against Early COVID-19
Treatment approved for people newly infected with COVID-19 who are at high risk for progressing to severe disease
Panel Recommends Against Approval of Experimental Drug for Alzheimer Disease
FDA panel concluded there is not enough evidence to support the clinical effectiveness of aducanumab
Regulators Discuss Approval of New Alzheimer Disease Drug
Aducanumab does not cure or reverse Alzheimer disease; high dose may slow mental decline
FDA Requiring Labeling Changes to NSAIDs Warning of Risks in Pregnancy
Labeling must indicate risks to unborn baby with NSAID use at 20 weeks of pregnancy or later
FDA Warns Companies About Illegal Sales of Dietary Supplements
The supplements contain cesium chloride, but no cesium chloride-containing products are FDA-approved
Maker of Antibody Cocktail Trump Took Seeks Emergency Use Authorization
Although effectiveness has not yet been seen in humans, drug has shown promise in treating mild cases of COVID-19
White House Approves Tougher Rules for COVID-19 Vaccine Development
Guidelines recommend participants in late-stage trials be followed for a median of at least two months
