In an unusual move, FDA staff didn't take a position on Moderna's application for a booster shot, indicating there may be insufficient data to support one
Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.
’s application forFDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product.
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U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boostersScientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.
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FDA Neutral on Moderna Bid for Booster Ahead of Decisive MeetingThe FDA is keeping its cards close to the vest when it comes to the potential approval of a booster dose of Moderna’s COVID-19 vaccine.
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Moderna asks for booster clearance ahead of FDA panel meetingsAn FDA advisory committee will meet Thursday and Friday to discuss booster doses for the Moderna and Johnson & Johnson Covid vaccines.
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Moderna urges FDA to authorize a half-size booster dose of its Covid-19 vaccine for some adultsModerna is urging the FDA to authorize a half-size booster of its Covid-19 vaccine, according to a briefing document posted Tuesday, ahead of a key meeting of the agency's vaccine advisers.
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FDA Authorizes Tobacco-Flavored Vuse E-Cigarette, Rejects Its Fruity VersionsThe Food and Drug Administration authorized a tobacco-flavored e-cigarette made by Reynolds American and denied authorization for fruit-flavored refill cartridges, signaling its approach to sweet and fruity e-cigarette flavors that are popular among teens
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Merck asks FDA to authorize antiviral Covid pill for emergency useMerck has asked the FDA to authorize its antiviral Covid pill for emergency use. ScottGottliebMD weighs in: 'I think where the government misstepped is that we didn't invest enough in trying to scale up the manufacturing of therapeutics across the board.'
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