Evoke Pharma's Gimoti On Way To US FDA On 'Mixed' Data
Evoke Pharma's share price fluctuated wildly after it announced new data for its gastroparesis therapy that were not quite as positive as they first appeared. A US filing is scheduled.
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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.
Positive Phase II data for Aptinyx’s novel NMDA receptor modulator are strong enough to take the product into a pivotal study in this difficult-to-treat area.
Orchard Therapeutics is on the cusp of the first approval for its ex vivo gene therapy, Libmeldy, for metachromatic leukodystrophy.