EndoQuest’s ELS robot posted striking early resection results. What will the FDA demand next?
EndoQuest completes PARADIGM enrollment with encouraging preliminary ESD results, setting up a critical FDA De Novo submission.
Medical Devices & Diagnostics
Pharma & Biotech
Can Anixa’s breast cancer vaccine and lira-cel CAR-T therapy translate early immune signals into clinical benefit?
Anixa Biosciences has presented completed Phase 1 data for its alpha-lactalbumin breast cancer vaccine and updated survival observations for liraltagene autoleucel in recurrent ovarian cancer. The findings strengthen the biological rationale behind both programmes, but controlled efficacy evidence, biomarker clarity and successful dose optimisation remain essential before either platform can be considered clinically validated.
Medical Devices & Diagnostics
How UpDoc’s clinical AI could transform insulin management without replacing physicians
UpDoc is moving patient-facing artificial intelligence beyond reminders and administrative support into insulin management. Its narrow FDA clearance, physician-defined limits and early clinical evidence reveal both the potential and the boundaries of autonomous chronic-disease care.
Pharma & Biotech
Why Anixa Biosciences’ Phase 2 breast cancer vaccine push matters more than the manufacturing deal itself
Anixa Biosciences is advancing its breast cancer vaccine toward Phase 2 after positive Phase 1 data. Read what this means for oncology watchers.
Medical Devices & Diagnostics
How Mitria Medical’s nitinol spacer challenges the edge-to-edge repair model for functional mitral regurgitation
Mitria Medical's Subvalvular Spacer reaches the U.S. under FDA compassionate use. What it means for FMR patients and what clinical evidence still needs to come.
Pharma & Biotech
How Anixa’s breast cancer vaccine could change immunoprevention strategies
Anixa Biosciences Inc. has reported final Phase 1 results for its investigational breast cancer vaccine targeting the α-lactalbumin protein, showing that the primary endpoints were met and 74 percent of participants demonstrated protocol-defined immune responses. The data were presented at the 2025 San Antonio Breast Cancer Symposium and build the case for a Phase 2
Features & Analysis
Why are “retired proteins” the hottest new targets in cancer immunotherapy research?
Few ideas have captivated both the scientific imagination and biotech investment flows quite like the cancer vaccine. For decades, the industry narrative was full of hope—and disappointment. The graveyard of failed trials stretches from Dendreon’s Provenge to once-hyped peptide and dendritic cell platforms. For every announcement of an “immune breakthrough,” there seemed to be a