Last week, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and ...

Moderna’s newest lower-dose COVID-19 vaccine is approved for all adults 65 and older, and for people aged 12 to 64 who are at ...

The FDA is defending a decision to restrict access to a newly-approved low dose COVID vaccine from Moderna that the company ...

The Food and Drug Administration has approved a new COVID-19 vaccine. Moderna's new option is a lower-dose version.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

The biotech’s mRNA vaccines were lauded by the first Trump administration but now are caught up in government changes to ...

The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It’s made in a way that allows ...

Federal health officials have changed the game for COVID vaccine access. Pregnant moms and others who rely on them to protect a high-risk family member are scared.

The biotech giant that soared during Operation Warp Speed now faces regulatory hurdles, political scepticism, and dwindling ...

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria ...

Cuts in NIH grants and the threat of more are discouraging investment and may drive trials out of the United States.

Pediatric patients exhibited high risk for severe avian influenza A/H5N1, suggesting clinical therapeutic and vaccine trials should be prioritized in this population.