Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

The delay dovetails with moves by Republican lawmakers in at least 7 states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal approval ...

"As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our is ready for ...

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...

Kennedy Jr., and that the deputy commissioner at the FDA intervened in the Novavax decision, are fueling concerns about the anti-vaccine beliefs of RFK Jr. and the potential impact to the industry.

A top FDA official directly intervened in an agency review of Novavax’s Covid-19 vaccine, pausing the approval process to ask for more data on the shot, according to four people familiar with ...

The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency ...

The delay dovetails with moves by Republican lawmakers in at least 7 states to ban or limit mRNA vaccines. HealthDay News — The US Food and Drug Administration (FDA) has delayed the full ...

In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for ...

Kennedy Jr., and that the deputy commissioner at the FDA intervened in the Novavax decision, are fueling concerns about the anti-vaccine beliefs of RFK Jr. and the potential impact to the industry.

Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. The agency is also ...