FDA reversals on UniQure, Moderna approvals worry investors

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Investors are concerned about the fates of multiple experimental drugs for hard-to-treat diseases following a string of recent rejections from the U.S. Food and Drug Administration.  The FDA in the past year has denied or discouraged the applications of at least eight drugs, according to RTW Investments, including a gene therapy for Huntington’s disease from […]


FDA vaccine head will step down in April after string of controversial decisions

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The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human Services Headquarters in Washington, April 22, 2025. Nathan Posner | Anadolu | Getty Images A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments will step down from the agency following […]


FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk

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The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, Nov. 24, 2025. Tom Little | Reuters The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts […]


Mass egg recall over salmonella concerns expands, FDA says

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Black Sheep Egg Company recalled several cartons of its free-range large grade A brown eggs due to the potential that they may be contaminated by salmonella, federal health officials said. Black Sheep Egg Company initiated a recall following a Food and Drug Administration (FDA) inspection that found 40 environmental samples at its egg processing facility tested […]


FDA approves Signos glucose monitoring for weight loss

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Woman with Signos wearable and app Source: Signos The Food and Drug Administration on Wednesday approved the first-ever glucose monitoring system specifically for weight loss from the startup Signos, establishing a new option for Americans to manage their weight.  Current treatment options for losing weight – popular drugs like GLP-1s and surgical interventions – are […]


FDA pulls Friendly’s Ice Cream pulled from shelves

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Ice cream lovers may have more than a meltdown. Friendly’s Ice Cream has recalled one of its most popular flavors after a packaging mix up sparking an allergy risk warning from the Food and Drug Administration, which who said it could cause “a serious or life-threatening allergic reaction.” DFA Dairy Brands, LLC, voluntarily pulled 324 […]


Sarepta stock falls on FDA gene therapy Elevidys comment

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Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023. Michael Nagle | Bloomberg | Getty Images Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk. The […]


Whoop says FDA is ‘overstepping’ with blood pressure feature warning

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The logo for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America’s food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025. Nathan Posner | Anadolu | Getty Images The U.S. Food and Drug Administration on Tuesday published a warning […]


FDA approves Gilead HIV prevention injection lenacapavir

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The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus.  But the launch of the injectable drug, which will be marketed under the name Yeztugo, […]


FDA guts education, training division as part of RFK Jr.’s cuts

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The Food and Drug Administration has gutted a division responsible for training agency staff and outside health-care professionals on an array of key public health, regulation and safety practices and supporting professional development for employees, CNBC has learned.  In an email viewed by CNBC, workers were notified that the Division of Learning and Organizational Development, […]