October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
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Deal Snapshot: Akeso has already sought to secure FDA approval for its PD-1 inhibitor, but the agency has shown reluctance to approve drugs based on China-only data.
Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
One of the architects of AstraZeneca’s burgeoning cancer portfolio, oncology R&D head Susan Galbraith is making sure the firm does not rest on its laurels. She talked to In Vivo about what’s coming next from the UK major’s cancer pipeline.