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Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
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AnHeart Therapeutics Signs Exclusive License Deal with Nippon Kayaku for Taletrectinib
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China-based AnHeart Therapeutics has announced the signing of an exclusive license deal with Japan-based biopharma Nippon Kayaku Co., Ltd. This strategic partnership grants Nippon Kayaku marketing and distribution rights for AnHeart’s leading pipeline candidate, taletrectinib, a next-generation ROS1 inhibitor. Taletrectinib: A Promising Treatment for ROS1-Positive NSCLCTaletrectinib is an oral, potent,…
