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FDA approves GSK's RSV vaccine for older adults, world's first shot against virus

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[ad_1] A GSK lab in London. Oli Scarff | Getty Images The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. The approval, the first ever globally by a regulatory body for an RSV vaccine , is a decisive victory for GSK in a race against drugmakers Pfizer and Moderna to bring to market a shot that targets the respiratory syncytial virus . Shares of GSK rose nearly 2% Wednesday following the approval. GSK's chief scientific officer Tony Wood said in a statement the decision "marks a turning point" in the company's effort to reduce the "significant burden" of RSV. The company will now focus on ensuring eligible older adults in the U.S. can access the vaccine "as quickly as possible," he said. GSK will also work toward regulatory review and approval of the shot in other countries. London-based GSK during an earnings presentation last week said it has "mil...

EU expands Wegovy, Ozempic probe over suicide risks to include other weight loss, diabetes drugs

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[ad_1] In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, April 17, 2023. Mario Tama | Getty Images The European Union's drug regulator on Tuesday said it has broadened an investigation into the risk of suicidal thoughts and self-injury among patients taking Novo Nordisk 's Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes medications.  The European Medicines Agency didn't specify which additional drugs are now included in the investigation. But it could potentially include Eli Lilly 's diabetes drug Mounjaro, which is approved in the EU . Other companies such as Pfizer and Amgen are developing similar products.  The EMA said it is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight loss and diabetes drugs. It's still unclear if the medicines caused the events or whether they are linked to patients' underlying ...