FDA Approves Qiagen’s Therascreen Urothelial Cancer Companion Diagnostic
The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.
Keeping Track: NME Approvals For Evenity And Balversa; Non-NME Approvals For Dovato And Keytruda; But An RTF For Fintepla
The latest drug development news and highlights from our US FDA Performance Tracker.
The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.