Vanda Pharmaceuticals, Inc.
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Latest From Vanda Pharmaceuticals, Inc.
Bristol Myers Squibb won US FDA approval for Augtyro (repotrectinib), from its $4.1bn Turning Point acquisition last year, in the treatment of ROS1-positive non-small cell lung cancer (NSCLC).
Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.
Company contends US FDA gave the committee ‘materially false and misleading information’ about ITCA 650 exenatide implant and did not focus on GLP-1 comparative claims as it seeks a hearing before the commissioner following the panel’s unanimous vote against the application.
Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.
- Specialty Pharmaceuticals
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