The panel unanimously said that the benefits of Moderna's mRNA jab outweigh its risks in preventing influenza in certain age groups.

All nine members of the committee unanimously voted to recommend Moderna's new mRNA influenza vaccine for adults 50 and over.

Moderna Inc.’s influenza vaccine made with mRNA technology was recommended for approval by outside advisers to the US Food and Drug Administration, a positive development for what has been a ...

By Christy Santhosh and Mariam Sunny June 18 (Reuters) - Advisers to the U.S. Food and Drug Administration on Thursday backed approval of Moderna's flu vaccine for adults aged 50 and older, saying its ...

A first-of-its-kind flu shot is one step closer to being available to the public after a Food and Drug Administration (FDA) ...

VRBPAC endorsed mRNA-1010 for adults 50-64 and ≥65 years, unanimously concluding benefits outweighed risks, supporting a late-stage regulatory path toward potential first mRNA seasonal influenza ...

A new kind of flu vaccine is moving a step closer to the U.S. market.

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics Lic ...

The US Food and Drug Administration on Friday approved the first flu vaccine that does not have to be administered by a health care provider, but it won’t be available in time for this respiratory ...

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Two of the companies are taking a second-go at FDA approval this summer, while another hopes to cement its leader-status in ...

The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in ...