EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen
Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy.
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Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker