For the 2025-2026 respiratory viral season, Moderna intends to have mResvia available for both FDA-approved patient populations.

GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to ...

The promise of mRNA technology seemed boundless after the success of the coronavirus vaccines, but Robert F. Kennedy Jr. has ...

Public health and infectious disease experts said they were surprised and confused about the move, and questioned why the HHS ...

The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include ...

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...

The U.S. Food and Drug Administration has approved Moderna’s (MRNA) RSV vaccine, mRESVIA (mRNA-1345), for preventing lower respiratory tract disease in adults aged 18 to 59 ...

Moderna said the FDA approved its new COVID-19 vaccine ... the Company's approved respiratory syncytial virus (RSV) vaccine." Moderna's original COVID-19 vaccine, Spikevax, generated $3.1 billion ...

Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect ...

The halt was triggered by an “imbalance,” the FDA said, in cases of severe lower respiratory tract infections (LRTIs) in children in a phase 1 trial of two Moderna RSV vaccines. One of the ...