Can VERAFEYE replace multiple tools in the electrophysiology lab? LUMA Vision moves closer to launch
LUMA Vision expands FDA clearance for VERAFEYE, integrating cardiac imaging, 3D anatomy and catheter tracking ahead of its planned 2027 launch.
Medical Devices & Diagnostics
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.
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.
Pharma & Biotech
Efti gets a new development path as Immutep investigates manufacturing link to Phase III setback
Immutep finds manufacturing differences after TACTI-004 and refocuses efti on head and neck cancer and sarcoma. See what comes next.
Pharma & Biotech
uniQure takes one-time Huntington’s gene therapy to FDA after pivotal regulatory turnaround
uniQure files AMT-130 for accelerated FDA approval after three-year Huntington’s disease data showed a 75% slowing in progression.
Pharma & Biotech
Verekitug moves toward pivotal trials as Upstream Bio targets quarterly dosing across two respiratory diseases
Upstream Bio sets Phase 3 plans for quarterly verekitug in severe asthma and CRSwNP after FDA discussions. See what the pivotal strategy means.
Pharma & Biotech
One-time OCU410 gene therapy enters Phase 3 as Ocugen targets geographic atrophy treatment burden
Ocugen starts Phase 3 testing of one-time OCU410 gene therapy after a 31% reduction in geographic atrophy lesion growth in Phase 2.
Pharma & Biotech
Remibrutinib clears pivotal multiple sclerosis tests with no liver safety signal as Novartis eyes approvals
Remibrutinib wins two Phase III multiple sclerosis trials as Novartis prepares global filings. See what the results mean for the BTK race.
Pharma & Biotech
Alvotech advances dual Entyvio biosimilar strategy as FDA accepts subcutaneous AVT80 application
FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.
Pharma & Biotech
CAD-1005 moves toward Phase 3 as FDA backs thrombotic endpoint strategy in heparin-induced thrombocytopenia
Cadrenal Therapeutics gains FDA alignment on a Phase 3 CAD-1005 trial in HIT after encouraging thrombosis data. See the risks and next steps.