(Reuters) -The U.S. Food and Drug Administration has lifted its clinical hold on ... combination shot and flu vaccine to ...
(RTTNews) - Novavax, Inc. (NVAX) Monday said the Food and Drug Administration or FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine ...
Novavax (NASDAQ:NVAX) shares climbed 12% premarket on Monday after the U.S. FDA lifted clinical hold on the investigational new drug application for the pharma firm’s COVID-19-Influenza ...
announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates.
Novavax can move forward with a trial for its combined Covid-19 and influenza vaccine after regulators lifted a clinical hold ... plans to file for FDA approval of its own combo vaccine by ...
The lifted hold applies to Novavax’s flu ... combo vaccine. A trial participant who’d received the shot in Jan. 2023 later developed motor neuropathy, or muscle weakness, leading the FDA ...
The clinical hold lift comes less than three months after Novavax’s JN.1-adapted COVID-19 vaccine was granted emergency use authorisation by the FDA for use in individuals aged 12 years and older. The ...
After evaluating the data, the FDA concluded that the ALS diagnosis was unrelated to Novavax’s vaccine. With the regulatory hold lifted ... by standard flu and Covid-19 vaccines.
Novavax Inc.’s stock fell ... Drug Administration has lifted the clinical hold placed on its COVID-19-and-flu combination and stand-alone flu vaccine candidates in October.
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found to be unrelated ...
(Reuters) -The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID ... flu vaccines after a safety concern was found unrelated to the ...
The US Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu ... shot, the company said. "The information provided to ...