Navi has FDA clearance and A$6.8m. Can Neonav turn neonatal catheter guidance into a U.S. hospital business?
Navi raises A$6.8 million to launch FDA-cleared Neonav in U.S. hospitals, targeting safer neonatal and paediatric vascular access.
Medical Devices & Diagnostics
Pharma & Biotech
FDA clears DYNE-302 Phase 1 trial targeting DUX4 in facioscapulohumeral muscular dystrophy
FDA clears Dyne’s Phase 1 DYNE-302 trial in FSHD, testing safety, DUX4 suppression and muscle-targeted siRNA delivery.
Pharma & Biotech
Pemvidutide cuts heavy drinking days in Phase 2 alcohol use disorder trial
Pemvidutide reduced heavy drinking days in Altimmune’s Phase 2 RECLAIM trial, but gastrointestinal side effects and limited patient diversity remain.
Pharma & Biotech
Atea eight-week hepatitis C regimen matches Epclusa in Phase 3 trial
Atea’s eight-week bemnifosbuvir and ruzasvir regimen matched 12-week Epclusa in a 905-patient Phase 3 hepatitis C trial.
Pharma & Biotech
Zirdafulven bladder cancer trial to test Lantern Pharma’s PTGR1 biomarker strategy
Lantern Pharma advances zirdafulven into a European Phase 1b/2 bladder cancer trial focused on PTGR1 and DNA repair biomarkers.
Medical Devices & Diagnostics
LyoGenesis Plus and Wynn Pharmaceuticals join Vector in critical-care manufacturing plan
Vector, LyoGenesis Plus and Wynn plan IV bag and vial adapter products, but definitive agreements and regulatory pathways remain ahead.
Medical Devices & Diagnostics
How EvoEndo plans to scale sedation-free endoscopy beyond academic medical centers
EvoEndo is widening sedation-free endoscopy access, but training, reimbursement and workflow will decide whether adoption scales.
Medical Devices & Diagnostics
Epitel’s $26m bet could take weeks-long wireless EEG monitoring beyond specialist centres
Epitel’s $26 million Series B will expand REMI wireless EEG monitoring, provider adoption and ambulatory seizure detection across the United States.
Pharma & Biotech
Can Galmed’s dissolving Aramchol film turn a former liver drug into a Parkinson’s contender?
Galmed’s Aramchol film may simplify Parkinson’s dosing, but clinical proof and regulatory clearance remain ahead. See what matters next.
Medical Devices & Diagnostics
How the Nexus acquisition of Telemetrix RPM could reshape hospital-to-home care
Nexus acquires Telemetrix RPM to link virtual nursing, remote monitoring and chronic care while facing major integration and reimbursement tests.