Could a sensor 10 times shorter challenge Dexcom and Abbott? Ascensia is betting on Sava
Ascensia backs Sava's $36M glucose microsensor push, but clinical validation and CE marking remain critical before its planned European launch.
Medical Devices & Diagnostics
Pharma & Biotech
Japan clears IMCIVREE for acquired hypothalamic obesity as Rhythm Pharmaceuticals expands global reach
Japan approves IMCIVREE for acquired hypothalamic obesity, expanding Rhythm Pharmaceuticals’ global franchise. See what the approval means for growth.
Medical Devices & Diagnostics
FIZE Medical receives CE marking and UKCA certification for FIZE kUO
FIZE Medical’s CE and UKCA milestones open Europe and Great Britain to FIZE kUO, shifting attention to ICU adoption and clinical evidence.
Pharma & Biotech
Tenpoint wants Yuvezzi to open a new UK presbyopia market, but another eye drop filed first
Tenpoint Therapeutics seeks UK authorisation for Yuvezzi, testing whether a dual-agent presbyopia eye drop can build a market beyond the United States.
Features & Analysis
Can early access programs reshape the approval arc for rare disease gene therapies?
GenSight Biologics S.A.’s early access rollout of GS010/LUMEVOQ in France and Israel has drawn new attention to how regulators are quietly repurposing compassionate use frameworks into strategic regulatory sandboxes for advanced therapies. As rare disease gene therapies edge closer to commercial viability, a patchwork of early access programs across key jurisdictions is beginning to influence