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

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

Six days after a senior FDA official sent a sweeping internal email claiming that COVID vaccines had caused the deaths of "at least 10 children," 12 former FDA commissioners released an extraordinary ...

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 ...

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

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

Wis., chairman of the Senate Homeland Security Subcommittee on Investigations, comes as lawmakers continue to examine the ...

The FDA announced that vaccine division lead Vinay Prasad will be stepping down following a short tenure marked by vaccine-focused conflict. HealthDay News — Dr. Vinay Prasad, who leads the U.S. Food ...

Six days after a senior FDA official sent a sweeping internal email claiming that COVID-19 vaccines had caused the deaths of "at least 10 children," 12 former FDA commissioners released an ...