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FDA Clears 131 Drugs in 2025 as Global Approval Momentum Surpasses Decade Average
FDA cleared 131 drugs in 2025, surpassing the 10-year average and intensifying manufacturing scale-up and CMO capacity demands.
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Sanofi Gains Japan MHLW Approval for Wayrilz in Immune Thrombocytopenia Following Phase 3 Data
Japan's MHLW grants Sanofi dual marketing and manufacturing authorization for Wayrilz in ITP, based on LUNA 3 phase 3 data.
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Sanofi Gains EU Approval for Cenrifki as First Disability-Targeting Therapy in Non-Relapsing SPMS
Sanofi's Cenrifki gains EC approval for non-relapsing SPMS, introducing mandatory liver monitoring and a phased EU launch starting in Germany.
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AbbVie Gains EC Approval for SKYRIZI in Pediatric Plaque Psoriasis with New Weight-Based Pre-Filled Syringe
EC approves AbbVie's risankizumab for pediatric psoriasis, introducing a 55 mg weight-based pre-filled syringe for patients under 40 kg.
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