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
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.
Medical Devices & Diagnostics
FDA clears expanded LUMA Vision VERAFEYE platform for real-time cardiac mapping and catheter guidance
LUMA Vision has secured additional FDA clearance for VERAFEYE, integrating real-time 2D and 3D cardiac anatomy, catheter tracking and procedural guidance ahead of a planned 2027 U.S. launch.
Pharma & Biotech
FDA accepts Nanoscope MOGENRY BLA for gene-agnostic treatment of severe retinitis pigmentosa
The FDA has accepted Nanoscope Therapeutics’ BLA for MOGENRY, an optogenetic therapy designed to restore useful vision in severe retinitis pigmentosa regardless of the underlying mutation.
Medical Devices & Diagnostics
HoneyNaps develops four-patch wireless PSG system to replace more than 24 wired sleep sensors
HoneyNaps has developed a four-patch wireless polysomnography platform capturing EEG, EOG, ECG, EMG, airflow and oxygen data while connecting with its FDA-cleared SOMNUM AI software.
Pharma & Biotech
FDA supports key NewRal trial design elements as Matricelf prepares spinal cord injury IND
FDA feedback supports major elements of Matricelf’s proposed first-in-human NewRal study in chronic complete thoracic spinal cord injury while requesting additional IND information.
Medical Devices & Diagnostics
CytoSorb linked to 37% less severe bleeding in urgent CABG patients taking ticagrelor
A 587-patient matched real-world analysis found severe bleeding in 21.8% of CytoSorb-treated urgent CABG patients versus 34.5% of controls, strengthening CytoSorbents’ planned DrugSorb-ATR De Novo resubmission.
Medical Devices & Diagnostics
FDA clears Medibyt CPETWise to automate cardiopulmonary exercise test analysis
Medibyt has received FDA 510(k) clearance for CPETWise, a software platform designed to standardize cardiopulmonary exercise test analysis while preserving clinician access to underlying physiological data.
Pharma & Biotech
Acepodia gets FDA clearance to test a two-payload ADC in advanced liver cancer
The FDA has cleared Acepodia’s ACE723 IND, allowing the GPC3-targeted dual-payload antibody-drug conjugate to begin Phase 1 testing in unresectable or metastatic hepatocellular carcinoma.
Medical Devices & Diagnostics
Nyxoah Genio hits both pivotal endpoints in sleep apnea patients excluded from current U.S. neurostimulation
Nyxoah’s ACCCESS pivotal study produced a 77.2% AHI responder rate and 87.7% oxygen-desaturation responder rate with no device-related serious adverse events through 12 months.