EU & Japan Drug Approvals — April 2026
EU & Japan Drug
Approvals — April 2026
The EU and Japan each delivered one landmark approval in April 2026. The EMA approved Moderna’s combined Influenza and COVID-19 mRNA vaccine — the first dual-pathogen mRNA vaccine approved in Europe. Japan’s PMDA granted Conditional Marketing Approval to Raguneprocel, the world’s first iPSC-derived cell therapy for Parkinson Disease.
2 drugs approved across EU and Japan — April 2026
All data from the April 2026 monthly report, Table 1. Both are first-in-class or first-of-modality events.
| Drug | Target | Modality | Indication | Developer | Region · Date |
|---|---|---|---|---|---|
| Moderna Influenza and COVID-19 mRNA Vaccine | SARS-CoV-2 S protein · Influenza HA | mRNA vaccine | Influenza; COVID-19 | Moderna Biotech Spain SLU | EU · Apr 20 |
| Raguneprocel | — | iPSC therapy | Parkinson Disease | Sumitomo Pharma Co., Ltd. | Japan CMA · Apr 17 |
Both approvals profiled
Moderna Influenza and COVID-19 mRNA Vaccine — first combined dual-pathogen mRNA vaccine in Europe
Moderna Influenza and COVID-19 mRNA Vaccine is an mRNA vaccine targeting SARS-CoV-2 S protein and Influenza HA, developed by Moderna Biotech Spain SLU. It was approved by the EMA on April 20, 2026 for Influenza and COVID-19 — the first combined dual-pathogen mRNA vaccine to receive EMA approval. The vaccine combines SARS-CoV-2 spike protein mRNA and influenza haemagglutinin mRNA in a single formulation, enabling simultaneous seasonal co-immunisation against both respiratory pathogens.
mRNA · SARS-CoV-2 S · Influenza HA · Dual-pathogen · EMARaguneprocel — first iPSC-derived cell therapy for Parkinson Disease globally
Raguneprocel is an iPSC (induced pluripotent stem cell) therapy developed by Sumitomo Pharma Co., Ltd. It received Conditional Marketing Approval from Japan’s PMDA on April 17, 2026 for Parkinson Disease — making it the first iPSC-derived cell therapy approved for a neurodegenerative disease indication globally. iPSC technology, pioneered by Japanese scientist Shinya Yamanaka (Nobel Prize 2012), generates patient-derived or allogeneic pluripotent cells that can be differentiated into dopaminergic neurons for transplantation in Parkinson disease.
iPSC · Parkinson Disease · CMA · Japan · Sumitomo3 signals from the EU & Japan April 2026 approval data
First combined Influenza + COVID-19 mRNA vaccine: EMA approval validates dual-antigen mRNA platform
Moderna’s EMA approval of a combined Influenza/COVID-19 mRNA vaccine validates the dual-antigen mRNA platform strategy for seasonal respiratory co-immunisation. By combining SARS-CoV-2 spike mRNA and influenza HA mRNA in a single lipid nanoparticle formulation, the vaccine eliminates the need for separate flu and COVID injections — reducing administration burden, improving compliance, and demonstrating mRNA’s flexibility as a multi-antigen vaccine platform across respiratory pathogens.
Raguneprocel: iPSC technology reaches clinical approval in Parkinson Disease — a global first
Raguneprocel’s PMDA Conditional Marketing Approval for Parkinson Disease is the first iPSC-derived cell therapy to receive regulatory approval for a neurodegenerative disease indication globally. The approval validates more than a decade of translational research in dopaminergic neuron differentiation from iPSCs — a scientific programme largely centred in Japan. Japan’s Conditional Marketing Approval pathway (similar to EMA CMA and China NMPA breakthrough CMA) enabled approval based on early efficacy and safety data with post-approval confirmatory requirements.
Japan’s CMA pathway enabling regenerative medicine landmark approvals
Both Raguneprocel and the April 2026 ERP CMA cohort reflect Japan’s continued use of its Conditional Marketing Approval pathway to accelerate novel regenerative medicine approvals with limited Phase 3 data. Japan pioneered this framework specifically to enable iPSC and cell therapy products to reach patients faster under post-approval confirmatory commitments. Raguneprocel follows Japan’s earlier iPSC approvals in ophthalmology (macular degeneration), extending the iPSC clinical platform into a major neurodegenerative disease for the first time.
Moderna’s combined vaccine signals multi-antigen mRNA platform commercial maturity
The EMA approval of Moderna’s Influenza + COVID-19 mRNA vaccine demonstrates that mRNA vaccine platforms have reached the commercial maturity to deliver multi-antigen combination products beyond single-pathogen COVID-19 indications. This approval, following Moderna’s earlier single-antigen flu mRNA programmes, signals a progression toward next-generation respiratory combination mRNA vaccines — potentially extending to RSV, influenza subtypes, and SARS-CoV-2 variants within a single seasonal vaccination product.
EU & Japan drug approvals April 2026 — key questions
2 drugs received approval across EU and Japan in April 2026: Moderna Influenza and COVID-19 mRNA Vaccine (EMA, April 20, 2026, for Influenza and COVID-19) and Raguneprocel (Japan PMDA Conditional Marketing Approval, April 17, 2026, for Parkinson Disease).
Moderna Influenza and COVID-19 mRNA Vaccine, targeting SARS-CoV-2 S protein and Influenza HA, developed by Moderna Biotech Spain SLU, was approved by the EMA on April 20, 2026 for Influenza and COVID-19 — the first combined dual-pathogen mRNA vaccine approved by EMA.
Raguneprocel is an iPSC (induced pluripotent stem cell) therapy developed by Sumitomo Pharma Co., Ltd. It received Conditional Marketing Approval from Japan’s PMDA on April 17, 2026 for Parkinson Disease — making it the first iPSC-derived cell therapy approved for a neurodegenerative disease indication globally.
The combined Influenza and COVID-19 mRNA Vaccine was developed by Moderna Biotech Spain SLU (a subsidiary of Moderna). It received EMA approval on April 20, 2026 for Influenza and COVID-19.
Raguneprocel’s Conditional Marketing Approval from Japan’s PMDA for Parkinson Disease marks the first approved iPSC (induced pluripotent stem cell)-derived cell therapy for a neurodegenerative disease globally. It represents a major milestone for iPSC therapy — a cell therapy modality pioneered by Japanese researchers — receiving its first clinical approval in Japan for a major neurological indication.
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report, Table 1 (drug approvals). Represents a snapshot of available records as of April 2026.