Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its COVID-19 vaccine for people age 18 and older, and Pfizer and BioNTech ...

The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2. The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax ® and ...

Moderna announced the Food and Drug Administration has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax and mNEXSPIKE, targeting the LP.8.1 ...

WASHINGTON -- Moderna is applying for full government approval for its COVID-19 vaccine. The company said it is submitting trial data to the Food and Drug Administration on a rolling basis over the ...

The Food and Drug Administration (FDA) on Wednesday approved the updated version of Pfizer’s and Moderna’s COVID-19 vaccines for this upcoming respiratory viral season, but limited the approval to ...

The US Food and Drug Administration (FDA) has expanded approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot ...

“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” said Stéphane Bancel, Chief Executive Officer of ...

CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company’s ...