Vanda Pharmaceuticals, Inc.
http://www.vandapharma.com/
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Latest From Vanda Pharmaceuticals, Inc.
BMS Grows Its Lung Cancer Portfolio With ‘Best-In-Class’ Augtyro Approval
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).
Orphan Drugs Dominate Latest EU Filings
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.
Intarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’
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.
November US FDA User Fee Calendar: Takeda On Tap; Small Molecules For Cancer
Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.
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