The FDA has accepted United Therapeutics’ supplemental Tyvaso application for idiopathic pulmonary fibrosis after combined TETON data showed a 111.8 mL advantage in forced vital capacity over placebo at 52 weeks.
uniQure has submitted AMT-130 for accelerated U.S. approval after three-year Phase 1/2 data showed a 75% slowing of Huntington’s disease progression against a matched natural-history control.
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.
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.
Beyond Air’s LungFit GO has received FDA Breakthrough Device designation for nontuberculous mycobacterial pulmonary disease after a 15-patient pilot showed high-dose nitric oxide could be self-administered at home.
Ocugen has begun the 237-patient Phase 3 ArMaDa3 trial of OCU410, a one-time gene therapy for geographic atrophy after Phase 2 treatment reduced lesion growth by 31% at 12 months.
Digital twins and model-informed drug development are moving from research concepts toward regulatory infrastructure, raising the possibility that future pharmaceutical trials could use simulated patients to refine doses, predict outcomes and potentially reduce the number of people required in selected control groups.
Final MARRS pivotal-trial results show Perfuze’s FDA-cleared Millipede88 aspiration catheter achieved 89% successful reperfusion without rescue therapy and a 75% first-pass effect in M1 middle cerebral artery occlusions.
The FDA is warning patients who received mammograms at Mammography Center of Monterey on or after December 22, 2023 about possible image-quality problems after the facility failed an additional review and some deficiencies were classified as severe.
GE HealthCare’s Photonova Spectra has secured CE Mark after earlier U.S. FDA clearance and Japanese approval, accelerating the global expansion of photon-counting CT technology that promises higher-resolution and spectral imaging from individual X-ray photons.