Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
NanoViricides has received approval from the Democratic Republic of Congo's National Ethics Committee to proceed with Phase II clinical trials of NV-387 for MPox treatment, addressing a significant unmet need as no effective treatment currently exists.
Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.
Moderna has filed patent infringement lawsuits against Pfizer/BioNTech in multiple countries, claiming their Comirnaty vaccine infringes on mRNA technology patents that Moderna pioneered and invested billions in developing.
Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market.
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