Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues
The latest drug development news and highlights from our US FDA Performance Tracker.
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The company believes the PD-1 inhibitor’s recent declines will be reversed through new indications, providing revenue growth along with other new products by the time Revlimid faces generics in 2022.
Hot on the heels of winning EU fast-track review status for belantamab mafodotin, GlaxoSmithKline has asked the European Medicines Agency to grant accelerated assessment to another of its planned marketing applications.
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.