Can engineered Treg therapy scale? Cellares and Sonoma begin a crucial manufacturing test
Cellares will automate SBT-77-7101 manufacturing as Sonoma Biotherapeutics prepares its CAR-Treg program for larger clinical trials.
Pharma & Biotech
Medical Devices & Diagnostics
ReCET diabetes trial reaches 350 patients as Endogenex advances toward FDA submission
Endogenex, Inc. reported on July 8 that enrollment has been completed in its pivotal ReCET clinical study, a prospective, randomized, double-blinded and sham-controlled trial evaluating an investigational endoscopic procedure in adults with inadequately controlled type 2 diabetes. The study enrolled 350 participants across approximately 40 sites in the United States and Australia under a U.S.
Medical Devices & Diagnostics
iHealthScreen cleared a crucial FDA hurdle, but can iPredict-DR break AI eye screening’s adoption barrier?
iHealthScreen’s FDA-cleared iPredict-DR brings automated diabetic retinopathy screening closer to primary care, but adoption hurdles remain.
Pharma & Biotech
ART5803 gets FDA Fast Track status, but the real test for Arialys Therapeutics begins in Phase 2
FDA Fast Track status advances Arialys Therapeutics’ ART5803 as Phase 2 trials test a precision approach to anti-NMDA receptor encephalitis.
Medical Devices & Diagnostics
FDA clears Zeta’s robotic TMS system, but the real test begins inside busy clinics
Zeta Surgical wins FDA clearance for its robotic TMS system, advancing automated coil positioning and motion compensation in neuromodulation clinics.
Medical Devices & Diagnostics
Visby Medical’s FDA-cleared at-home PCR could reshape flu and COVID-19 testing
Discover how Visby Medical’s FDA-cleared at-home PCR could reshape flu and COVID-19 testing, treatment access, and diagnostics competition.
Pharma & Biotech
Otsuka reports VOYXACT preserved kidney function for two years in Phase 3 trial
Otsuka’s two-year VOYXACT data could reshape IgA nephropathy care. See what the eGFR results mean for FDA approval and clinical adoption.
Medical Devices & Diagnostics
Is RefleXion about to unlock a larger SCINTIX market with Anchor Point Tracking?
RefleXion Medical’s FDA filing for Anchor Point Tracking could extend the reach of SCINTIX autonomous radiotherapy, but clinical evidence and workflow economics remain critical.
Pharma & Biotech
Fizurex advances toward human trials as Steel Therapeutics completes pivotal safety study
Discover how Steel Therapeutics’ Fizurex toxicology milestone could reshape anal fissure treatment as the program advances toward an FDA IND.
Pharma & Biotech
Cogent advances third bezuclastinib FDA submission after APEX pivotal trial results
Cogent’s bezuclastinib NDA for advanced systemic mastocytosis is backed by APEX data showing 65% ORR and deep KIT-driven disease marker reductions.