Inmazeb combines three antibodies The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. “Today’s action demonstrates the FDA’s ongoing…
NBA players, staff already using saliva-based test extensively A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food…
Oral Treatment could prove effective against spinal muscular atrophy The U.S. Food and Drug Administration today approved Evrysdi (risdiplam) as an oral treatment for patients two months of age and older with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting…
Your coronavirus update for May 25; stay up to date with Elite. More than 5.4 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including more than 345,000 deaths. Healthcare officials in the United States have reported more than 1.6…
What’s causing medication errors, and what can your facility do to mitigate the risk of making them? The wrong drug. The wrong formulation. The wrong label. The wrong frequency. The wrong duration. These are many ways that medication errors can happen. And they do happen,…
FDA issued clinical trial guidance, though ‘Unavoidable’ protocol deviations are anticipated The U.S. Food and Drug Administration (FDA) issued clinical trial guidance last week for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA recognizes that the COVID-19…
Agency reiterates no drugs or vaccines are approved for COVID-19 treatment The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 treatment products. These products are unapproved drugs that pose significant…
Agency focused on generic drug applications Editor’s Note: The following information was reviewed from the FDA’s website. Last week, the U.S. Food and Drug Administration published a revision to Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments,…
Agency clarifies no reports of breaches have occurred thus far Last week, the U.S. Food and Drug Administration issued a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers. …
Postmarket drug safety surveillance practices under scrutiny In 2016, the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Food and Drug Administration (FDA) to prepare a summary analysis of adverse drug reaction…
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