The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

After the FDA asked for more clinical data in May 2025, Moderna has decided to resubmit the BLA later this year.

This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they are safe and effective.

A combination shot for flu and COVID-19 using messenger RNA generated antibodies in a study, but U.S. government regulators ...

Moderna has secured FDA approval for its respiratory syncytial virus (RSV) vaccine, giving it a chance to generate revenue from a second product as sales of its Spikevax COVID-19 shot have slumped.

Moderna on Thursday pushed back the time frame for likely approval of a combination vaccine meant to protect against both COVID-19 and influenza, but said exchanges with U.S. drug regulators have ...

Moderna Q1 EPS loss of $(2.52) beat estimates, while revenue hit $108 million, topping forecast despite falling from last year. Spikevax sales reached $84 million in Q1; RSV vaccine mRESVIA saw $2 ...

Moderna currently has two marketed vaccines in its portfolio — the COVID-19 vaccine Spikevax and the recently launched RSV vaccine mResvia. Product sales were down 49% year over year to $86 ...

Moderna's Q1 earnings reveal a significant revenue ... Likewise, the company is pursuing regulatory approval of an RSV vaccine for high-risk adults aged 18 to 59. This would effectively extend ...

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.