Madrigal Pharmaceuticals’ (NASDAQ:MDGL) shares surged 28% after the Food and Drug Administration (FDA) approved its lead asset, resmetirom, as the first U.S.-approved therapy for nonalcoholic steatohepatitis (NASH). This new pill, called REZDIFFRA, is a big deal in medical history because, until now, there were no FDA-approved treatments for NASH, which is a serious liver condition. NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH), has been a big problem without any good solutions, so this approval is a major step forward. The FDA’s approval allows resmetirom to be used in combination with diet and exercise for adults with NASH and moderate-to-advanced liver fibrosis.
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