Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs
Executive Summary
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
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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.
Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu
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.
Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker