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Multi4 Medical Receives CE Mark Approval for Multi4 System to Perform Outpatient Bladder Cancer Treatment
Shots: Multi4 Medical received CE mark approval for the Multi4 System, an all-in-one bladder cancer treatment platform enabling treatment during the same outpatient visit without operating room use, anesthesia, or hospitalization The Multi4 instrument integrates local anesthesia delivery, tumor resection, automatic tissue extraction for pathology, & cauterization into a single endoscopic device, allowing awake pts…
May 6, 2026
Arrowhead Pharmaceuticals Licenses ARO-PNPLA3 to Madrigal Pharmaceuticals in a ~$1B Deal
Shots: Arrowhead has granted Madrigal an exclusive global license to ARO-PNPLA3, a RNAi therapeutic designed to reduce liver expression of PNPLA3 as a potential treatment of metabolic dysfunction-associated steatohepatitis As per the deal, Arrowhead will receive $25M upfront & ~$975M in development, regulatory, & sales milestones, with tiered royalties ranging from high-single digits to the…
May 6, 2026
Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer
Shots: Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer  PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…
May 5, 2026
Ortho Development Launches Trivicta Cementless Hip Stem for Primary Hip Arthroplasty
Shots: Ortho Development has reported the full US commercial launch of the Trivicta Hip Stem, a cementless triple-taper femoral component for primary total hip arthroplasty, following a controlled market introduction Trivicta system features a 35μm hydroxyapatite coating over sintered titanium beads to support early osteointegration, alongside standard & extended offset options, progressive neck lengths, &…
May 5, 2026
Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu
Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant) Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…
May 5, 2026
Celcuity
Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer
Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…
May 4, 2026
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