Keeping Track: After COVID Delays, US FDA Approvals At Last For Daxxify, Rolvedon (But A CRL For Alvotech)
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The firm plans to submit to the US FDA in the third quarter and with the European Medicines Agency in the fourth quarter based on positive Phase III study results.