Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

The U.S. Food and Drug Administration on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...

US regulators grant full approval to Novavax shot but sharply limit eligibility. New studies on heart risks required, raising ...

Novavax sees pathway to FDA approval after post-marketing commitments Swings to profit in Q1 Shares rise nearly 19% May 8 (Reuters) - Novavax (NVAX.O), opens new tab on Thursday tried to calm ...

First, to the best of your knowledge, is the post-marketing clinical trial requirement specific to Novavax's BLA filing or do you expect FDA will ask all COVID-19 vaccines, including the mRNA ...

The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

But we're working with the FDA. We plan on partnering with them ... And this isn't specific to Novavax, just in general. Are the authorities saying, hey, well, there needs to be a full-blown ...

The FDA is a massive agency charged with regulating ... Earlier this year, the Trump administration sought for drug manufacturer Novavax to commit to conducting a new clinical trial on its ...