Teva’s TEV-408 met the primary endpoint in a 50-patient Phase 2a celiac disease trial, significantly reducing gluten-induced intestinal damage while also limiting inflammatory-cell increases and gastrointestinal symptoms.
uniQure files AMT-130 for accelerated FDA approval after three-year Huntington’s disease data showed a 75% slowing in progression.
Stryker has completed the first hip arthroscopy using SportSuite Vision on Apple Vision Pro after securing FDA De Novo authorization for the spatial-computing surgical application.
BillionToOne has launched Northstar Origin, a laboratory-developed liquid biopsy add-on that combines cfDNA methylation and genomic signals to predict tumor tissue of origin from one blood sample.
Telix has completed enrollment of 350 patients in the Phase 3 BiPASS study testing Illuccix and Gozellix PSMA-PET with MRI before prostate biopsy and has aligned with the FDA on an NDA pathway.
Pyrotech Therapeutics has dosed the first participant in an 84-person Phase 1 study of PTT-121, an intravenous GSDMD inhibitor being developed initially for septic shock.
BioMarin Pharmaceutical has completed its acquisition of Alesta Therapeutics, adding Phase 1/2a candidate ALE1, an oral small molecule designed to target the metabolic abnormality driving hypophosphatasia.
Upstream Bio sets Phase 3 plans for quarterly verekitug in severe asthma and CRSwNP after FDA discussions. See what the pivotal strategy means.
Ocugen starts Phase 3 testing of one-time OCU410 gene therapy after a 31% reduction in geographic atrophy lesion growth in Phase 2.
Remibrutinib wins two Phase III multiple sclerosis trials as Novartis prepares global filings. See what the results mean for the BTK race.