What will Eloxx Pharmaceuticals’ EXACT trial reveal about exaluren in Alport syndrome?
Eloxx starts Phase 2b testing of exaluren in nonsense mutation Alport syndrome, with a 16-week biomarker readout expected in mid-2027.
Pharma & Biotech
Medical Devices & Diagnostics
CraniUS has cleared its first skull implant. The bigger NeuroPASS ambition is still investigational
FDA clears the patient-specific CraniUS Plate for cranial defect repair, giving CraniUS its first U.S. product while NeuroPASS remains investigational.
Medical Devices & Diagnostics
AEYE-DS can screen for diabetic retinopathy in about a minute. Is accuracy enough to change primary care?
Peer-reviewed AEYE-DS trials show high sensitivity, specificity and imageability, testing whether autonomous retinal AI can expand diabetes screening.
Pharma & Biotech
FDA accepts Nanoscope Therapeutics’ MOGENRY BLA for severe retinitis pigmentosa
FDA accepts Nanoscope’s MOGENRY BLA for severe retinitis pigmentosa, moving a mutation-independent optogenetic therapy into formal review.
Medical Devices & Diagnostics
Emboliner captures more TAVR debris, but will FDA clearance translate into fewer strokes?
FDA clears Emboline’s Emboliner for embolic protection during TAVR, opening a U.S. launch after head-to-head testing against Sentinel.
Pharma & Biotech
UCB gets FDA Breakthrough Therapy designation for certolizumab pegol in high-risk APS pregnancy
FDA grants UCB Breakthrough Therapy status for certolizumab pegol in high-risk APS pregnancy, based on promising but non-randomized Phase 2 evidence.
Pharma & Biotech
Can Insilico Medicine’s rentosertib slow FVC decline in Phase 3 IPF study?
Insilico Medicine starts Phase 3 testing of rentosertib in IPF, putting its AI-discovered TNIK inhibitor through a decisive 52-week trial.
Pharma & Biotech
What does Samsung Biologics’ new $262m Songdo manufacturing deal signal?
Samsung Biologics adds a $262 million manufacturing deal through 2033 as its capacity, acquisitions and global CDMO ambitions expand.
Medical Devices & Diagnostics
Can a wearable replace repeated vancomycin blood draws? Nutromics gets a key FDA designation
Nutromics gains FDA Breakthrough Device status for its continuous vancomycin monitoring patch, but clinical validation remains the decisive test.
Pharma & Biotech
Seismic Pharmaceuticals starts Phase 3 istaroxime trial in cardiogenic shock
Seismic Pharmaceuticals begins Phase 3 testing of istaroxime in cardiogenic shock, putting a 600-patient global trial at center stage.