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.
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Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
Ahead of advisory committee review, agency cites poziotinib’s marginal anti-tumor activity, high rates of toxicity, and lack of dose optimization. Company seeks accelerated approval but was given standard review.