EU Accelerated Assessment Tracker
Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency
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Speedy EU Review For AZ/DS's Enhertu; Cheer Too For BMS/bluebird, Celgene And Rhythm
The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
Sanofi, Regeneron Seek Fast-Track Reviews From EMA
EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.
Roche Seeks Speedy EMA Review For SMA Drug Risdiplam
Applications to market Roche’s spinal muscular atrophy drug have already been submitted in eight countries including the US, where a decision is due in August.