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The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...
The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...
Four months after giving Eli Lilly’s Alzheimer’s disease treatment a thumbs-down, Europe’s Committee for Medicinal Products ...
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
The U.S. Food and Drug Administration recently announced plans to help states and Indian tribes purchase certain prescription drugs from Canada, where brand-name medicines tend to be cheaper because t ...
The U.S. Food and Drug Administration (FDA) announced a landmark decision on April 10, 2025, phasing out mandatory animal ...
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
Paxlovid is an antiviral combination therapy that can reduce the risk of COVID-19 causing severe illness, hospitalization and ...
A specific lot of pear slices in juice is being recalled across the U.S. due to higher levels of lead and cadmium. W.W.
Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...
FDA Commissioner Marty Makary is spearheading a major overhaul of the agency’s dietary guidelines, including rewriting the 1992 food pyramid.
The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug ...