Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Chief medical officer Samit Hirawat outlines R&D successes – though there have been some setbacks since it bought Celgene for $74bn last year – and the company’s commitment to clinical trial diversity.
Trelegy, already approved for COPD, will be targeted to the roughly one-third of asthmatics not controlled on maintenance therapy.
Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.