Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...

Novavax later announced the FDA instead was asking it to run an additional trial after approval, which is highly unusual. FDA did order several additional trials to be completed in the next few ...

The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just ...

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned ...

Novavax's combo and standalone flu vaccines showed strong immune responses and good safety in a Phase 3 trial of adults 65 and older.

Novavax's COVID-19-influenza vaccines show strong immune response in older adults, paving the way for regulatory approval.

The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It’s made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spi ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions — by its April 1 ...