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Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device
Shots: Vesalio has received the US FDA 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device with an integrated distal filter  pVasc NET builds on the pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter for non-surgical removal of emboli & thrombi from peripheral blood vessels pVasc NET features a fine-pore,…
August 14, 2026
BMS
BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)
Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…
August 14, 2026
Pharming Group Launches Joenja in Japan for APDS
Shots: Pharming Group has launched Joenja in Japan for activated PI3K delta syndrome (APDS) patients aged 4 years and older following NHI reimbursement listing As per the agreement with Pharming, OrphanPacific serves as Joenja’s Marketing Authorization Holder in Japan &, alongside Pharming, manages the product’s supply & distribution Leniolisib is under regulatory review for pediatric…
August 13, 2026
Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC
Shots: The companies have reported the global P-III (REZILIENT3) trial assessing zipalertinib + Pt-based CT vs CT alone in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations Trial met its 1EP of PFS, showing improvement with the zipalertinib-containing regimen at interim analysis, with the IDMC recommending unblinding the…
August 13, 2026
Elevation Spine Receives FDA Clearance for Saber-XA ALIF System
Shots: The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…
August 12, 2026
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