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

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

美国食品药品监督管理局（FDA）在本月初居然没能按时对诺瓦瓦克斯（Novavax）公司的新冠疫苗审批做出决定，就好像约好的朋友放了鸽子，错过了原定的截止日期。可诺瓦瓦克斯公司那是相当执着，依旧拍着胸脯坚信自家基于蛋白质的疫苗值得获得常规批准，仿佛在说 ...

Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

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

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...

Novavax is working with the FDA to meet additional requirements and hopes to secure full approval as soon as possible.

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

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...