Shots:
- FDA has approved the BLA for Nuvaxovid against COVID-19 in adults (≥65yrs.) & individuals (12-64yrs.) with at least one underlying condition increasing risk of sev. COVID-19 based on a P-III trial, showing favorable safety & efficacy; commercially available in US this fall pending strain selection at FDA VRBPAC meeting on May 22, 2025
- FDA has requested a PMC to conduct a P-IV trial evaluating Nuvaxovid vs PBO in adults (50–64yrs.) without high-risk conditions; Novavax is working with Sanofi to assess funding & execution for new trial
- Approval triggers a $175M milestone under Novavax & Sanofi’s May 2024 deal, with Sanofi leading marketing & Novavax receiving tiered royalties on future sales
Ref: Prnewswire | Image: Novovax | Press Release
Related News:- GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
