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.
The FDA granted accelerated approval for the small but significant HER2-mutated NSCLC indication, while the arbitrator in Seagen’s arbitration case ruled in Daiichi Sankyo’s favor.