Drug Approval | August 29, 2025
Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
mRNA-1010 demonstrated superior relative vaccine efficacy
The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines
The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program
The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
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