Keeping Track: Poteligeo, Onpattro, Galafold And Annovera Approved; Selinexor Submitted
The latest drug development news and highlights from our US FDA Performance Tracker.
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Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.
Public Company Edition: Phathom went public in the US within proposed pricing terms, but Cabaletta’s IPO went to market below a proposed range, while TFF launched in line with earlier plans. Also, Principia’s FOPO raises $210m and Trillium restructures.