Sanofi Challenges EMA’s Refusal Of New Active Substance Status For Nexviadyme
Sanofi wants the European Medicines Agency to re-examine its opinion that the company’s drug for Pompe disease does not qualify as a new active substance.
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Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
England’s health technology assessment body said it would continue to work with Seagen to address the reasons why its newly published draft guidance has recommended against using Tukysa on the National Health Service.