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 ...
Novavax can move forward with a trial for its combined Covid-19 ... the clinical hold on its investigational new drug application for its combined vaccine and its standalone flu 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 ...
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.
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 ...
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 ...