Rapid Medical’s steerable guidewire has FDA clearance, but can it shorten stroke access time?
Rapid Medical's DRIVEWIRE 35 gains FDA clearance for steerable vascular access, with stroke adoption now hinging on real-world workflow evidence.
Medical Devices & Diagnostics
Pharma & Biotech
Eli Lilly’s psychedelic deal carries a US$3.8bn headline, but the fine print tells the real story
Eli Lilly’s AtaiBeckley deal brings psychedelic medicine into big pharma’s M&A race, but Phase 3 data and rescheduling still decide its value.
Medical Devices & Diagnostics
No battery, no pill, no sensor: Why ANF Care’s unusual wearable is entering the United States
ANF Care is taking BioCoherence wearable discs to the United States, where evidence, claims and launch execution will shape adoption.
Pharma & Biotech
IDEAYA Biosciences expands ESMO 2026 catalyst slate across eye and lung cancer
IDEAYA Biosciences will use ESMO 2026 to expand the clinical case for darovasertib across three uveal melanoma settings and test the durability of IDE849 responses in small-cell lung cancer.
Pharma & Biotech
South Korea kept Neuronata-R on the market. Now CorestemChemon’s harder test begins
South Korea keeps Neuronata-R available after Phase 3 review, but manufacturing, patient selection and a delayed U.S. filing remain decisive tests ahead.
Pharma & Biotech
CAM2029 is back before the FDA, but has Camurus finally cleared its manufacturing hurdle?
Camurus has restored a formal United States review timeline for CAM2029, but the December decision remains tied to third-party manufacturing compliance rather than new questions about clinical efficacy.
Medical Devices & Diagnostics
Can one ventilator protect the lungs and diaphragm together? Nihon Kohden puts NKV-550 to the test
Nihon Kohden adds Pmus monitoring and adaptive controls to NKV-550, but hospital adoption will depend on validation and workflow performance.
Pharma & Biotech
GemPharmatech just added a humanized liver model, but can it close the clinical translation gap?
GemPharmatech and Humlab Global expand access to humanized mouse models, but validation and adoption will determine their clinical value.
Pharma & Biotech
FDA gives Genentech’s Gazyva Priority Review for primary membranous nephropathy
FDA Priority Review puts Genentech’s Gazyva on a November decision path in primary membranous nephropathy after the Phase III MAJESTY win.
Pharma & Biotech
Multikine is back in Phase 3, but can CEL-SCI turn a striking subgroup signal into approval?
CEL-SCI launches a 212-patient Multikine Phase 3 study, but subgroup validation, funding and regulatory execution remain decisive.