There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

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

Federal regulators have requested that Novavax conduct an additional randomized clinical trial of its COVID-19 vaccine, a costly demand that could threaten the company’s ability to comply, The Wall ...

Novavax faces uncertainty as FDA requests a new clinical trial for its COVID-19 vaccine, the last protein-based option in the ...

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

Novavax has not received an official response from the FDA related to the status of the BLA. The BLA was based on data from a phase III study, which showed the vaccine was safe and effective for ...

Shares of Novavax (NVAX) are under pressure on Thursday ... composition as the reason for the push back, adding that the FDA is “shifting our priorities to multiple-antigen vaccines.” ...

When asked if the delay resulted from "personnel being shuffled" at the FDA, Kennedy attributed it to the vaccine's composition. He said Novavax's single antigen approach "has never worked" for ...

The FDA gave full approval to COVID-19 shots from ... PRICE ACTION: In Thursday morning trading, shares of Novavax have dropped over 24% to $5.13. Published first on TheFly – the ultimate ...

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 ...

Novavax intends to seek a business partner to ... And Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who was instrumental in the development and ...