Novavax (NASDAQ:NVAX) shares climbed 12% premarket on Monday after the U.S. FDA lifted clinical hold on the investigational ...

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 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 ...

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.

The FDA has granted fast track designation to two combination vaccine candidates that aim to protect adults 50 and older from both influenza and COVID-19, according to a Dec. 16 AJMC report. These ...

Sanofi SNY announced that the FDA has granted ... and Flublok flu vaccines. Novavax recently signed a multi-billion dollar deal with Sanofi for its protein-based COVID-19 vaccine.

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.

Novavax NVAX announced that it has started dosing participants in the phase III study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.