Moderna announced the change Wednesday, about a week after revealing that the FDA's vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology. The dispute centred over a 40,000-person clinical trial that concluded Moderna's new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA's rare "refusal to file" letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically ...

Vaccine specialist Moderna (NASDAQ: MRNA) stock soared 5.5% through 12:55 p.m. ET Wednesday after The Wall Street Journal reported that the U.S. Food and Drug Administration will accept (note: "accept," but not automatically "approve") Moderna's application to sell a new seasonal flu shot good for the 2026-2027 flu season. Image source: Getty Images. Will AI create the world's first trillionaire? Our team just released a report on the one little-known company, called an "Indispensable Monopoly" providing ...

The stock’s movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.Following a Type A meeting, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, inclu ...

格隆汇2月19日｜莫德纳表示，已与监管机构展开进一步磋商，并宣布美国食品药品管理局(FDA)将受 理该公司采用mRNA技术的流感疫苗上市申请。就在上周，该监管机构以研究设计存在缺陷为由，拒绝 受理莫德纳这款新型流感疫苗的审核申请。但据公司称，在后续沟通中，FDA改变立场，同意启动审核 流程。 ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Moderna (MRNA) stock jumped more than 6% on Wednesday after the US Food and Drug Administration agreed to review the drugmaker's first flu shot of the season, reversing course on a decision to reject the review last week. Moderna recently developed a new flu vaccine using the same mRNA technique that underpins its COVID-19 vaccine. But after requesting review from the federal government, the FDA initially declined to review the drug — a necessary regulatory step toward bringing the drug to market — saying ...

A researcher works in the lab at the Moderna Inc. headquarters in Cambridge, Massachusetts, US, on Tuesday, March 26, 2024.Moderna said on Wednesday the Food and Drug Administration has agreed to review its experimental mRNA flu shot, reversing the agency's earlier decision to refuse to accept the application in a move that stunned Wall Street and the medical community. The announcement clears a path forward for the vaccine, which is key to Moderna's experimental combination Covid-flu jab and the company's ...

Moderna's stock was surging after the FDA said it would review the biotech's flu-vaccine candidate, a week after it had refused to do so. ...

Pharma giant Moderna Inc (NASDAQ:MRNA) is enjoying a boost today, after the U.S. Food & Drug Administration (FDA) accepted the company's flu vaccine application for review. The company made modifications to the application after it was rejected last week. MRNA was last seen up 5.7% to trade at $46.45, heading for a third-straight gain as it moves back toward its Jan. 22 more than one-year high of $55.20. Since the start of the year, the equity is already up 55.4%. A bout of short covering could help push Mo ...

疫苗生产商Moderna表示，美国食品和药物管理局(FDA)已同意审查其 流感疫苗申请，推翻了早些时候 拒绝该申请的决定。Moderna表示，FDA已经接受了其提出的修订方案，即寻求全面批准50至64岁的成 年人注射该疫苗，并加速批准65岁及以上的成年人注射该疫苗。该公司还补充称，将对老年人进行上市 后研究。 ...