The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

A blanket requirement for placebo-controlled trials threatens research ethics and vaccine access, it’s being argued.

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...

Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for ...