Pfizer’s Talazoparib Among Bumper Crop Of New Products Under Review By EMA
Fourteen new products have been added to the European Medicines Agency’s list of medicines under review for marketing authorization across the EU.
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Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan
The latest drug development news and highlights from our US FDA Performance Tracker.
Dova’s avatrombopag, which was recently approved in the US under priority review, has been refused an accelerated assessment in the EU.