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Mar 14, 2026
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Feb 27, 2026
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Feb 26, 2026
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
Feb 25, 2026
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Feb 17, 2026
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
Feb 17, 2026
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Feb 12, 2026
The European Commission has granted marketing authorization for Moderna's mNEXSPIKE (mRNA-1283) COVID-19 vaccine for individuals aged 12 years and older across all 27 EU member states plus Iceland, Liechtenstein and Norway.
