Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

The company has had its ups -- the approval of its respiratory syncytial virus (RSV) vaccine back in 2024 -- and its downs -- the failure of its cytomegalovirus (CMV) vaccine candidate in a phase 3 ...

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

Signed Memorandum of Understanding supports "Plan Mexico," Mexico's strategic initiative to build a local mRNA ...

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

President Trump called Commissioner Marty Makary to the White House to discuss his frustration with the agency handling of ...

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

Vaccine specialist Moderna ( MRNA +4.92%) stock soared 5.5% through 12:55 p.m. ET Wednesday after The Wall Street Journal ...

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

Moderna made a fortune with COVID vaccines, but revenue has since declined.

Reports fourth quarter revenue of $0.7 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.11)Reports ...