Opioid Producer Fined $1 Billion for Misbranding

DEA administrator says such companies have contributed to the opioid crisis. The Department of Justice announced that Endo Health Solutions, Inc. (EHSI) was ordered to pay $1.09 billion…

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First Lady Speaks at NYSE Women’s Health Summit

The event seeks to increase investment in women’s health. First Lady Jill Biden spoke at the Women’s Health Investor Summit at the New York Stock Exchange in Manhattan…

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FDA Warns Against Over-the-Counter Pain Relief Products for Cosmetic Procedures

Six companies receive warning letters as the FDA addresses unsafe topical analgesics and urges consumer vigilance. The U.S. Food and Drug Administration (FDA) has cautioned against using specific…

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FDA Approves Medication for Liver Scarring

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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