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- MDCG: Only manufacturers should assign UDI-DIsThe European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
- Dyne Therapeutics receives early 2027 FDA decision date for Duchenne therapy, analysts anticipate smooth reviewDyne Therapeutics' investigational Duchenne muscular dystrophy therapy, zeleciment rostudirsen, has had its BLA accepted by the FDA with a target action date of Jan 21, 2027. Analysts at Oppenheim…