Novavax on Thursday swung to a first-quarter profit from a year-ago loss, helped by reduced costs related to the development and sale of its COVID-19 vaccines, its only product on the market.

Officials in sixteen states and the District of Columbia sued in response, leading to Tuesday’s order from U.S. District ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine is sowing uncertainty about other ...

Senior leaders at the US Food and Drug Administration began pushing Moderna Inc. and Pfizer Inc. to file for full, formal ...

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

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

The FDA has already delayed the approval of Novavax’s updated Covid vaccine, requiring the company to carry out a new ...

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

Robert F. Kennedy Jr., who oversees the FDA, intends to set new regulatory standards vaccine manufacturers couldn’t possibly ...

The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi. Novavax ...