The medication was fast-tracked through the agency’s accelerated approval pathway. The U.S. Food and Drug Administration (FDA) has authorized Rezdiffra (resmetirom) for adults experiencing noncirrhotic non-alcoholic steatohepatitis (NASH),…
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President Signs Executive Order on Women’s Healthcare Research
The first lady says the support for research will allow women to get the healthcare they need. President Joe Biden signed an executive order this week that directs…
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FDA Approves Cellular Therapy for Advanced Melanoma
Approval provides early access to therapy while clinical trials continue. The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults…
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FDA Finding Prompts Recall of Eye Ointment Products
The agency reported one of the products lacked the assurance of sterility. The Food and Drug Administration (FDA) issued an announcement this week that four types of eye…
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FDA Approves Xolair for Food Allergy Treatment
Associate Director Stone says the injection, while not a cure, “will help reduce the health impact if accidental exposure occurs.“ U.S. Food and Drug Administration (FDA) has approved…
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First Lady Promotes Women’s Health Research in Atlanta
She highlights the White House Initiative on research for women’s health launched last fall. First Lady Jill Biden promoted the White House Initiative on Women’s Health Research on…
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FDA Approves Gene Therapies for Sickle Cell Disease
Two cell-based gene therapies will address the debilitating hereditary blood disorder. The U.S. Food and Drug Administration (FDA) has granted approval of two groundbreaking cell-based gene therapies, Casgevy…
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FTC Sues to Block Acquisition of Exclusive Drug License
The deal would give the French company a pharmaceutical monopoly over Pompe Disease therapy. The Federal Trade Commission (FTC) has taken action to prevent Sanofi from acquiring an…
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FDA Approves Tyruko for Multiple Sclerosis and Crohn’s Disease Treatment
Medication offers options to those who have relapsing forms of the disease. The U.S. Food and Drug Administration (FDA) has authorized Tyruko (natalizumab-sztn), the first biosimilar to Tysabri…
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