Browsing Tag
U.S. Food and Drug Administration
105 posts
Thryv Therapeutics secures FDA IND clearance to launch first potential drug for Long QT syndrome
Thryv Therapeutics gains FDA IND clearance for THRV-1268 in Long QT Syndrome, aiming to pioneer the first disease-modifying therapy for this rare disorder.
Vinay Prasad returns to top FDA post amid political whiplash and gene therapy fallout
Dr. Vinay Prasad has been reinstated as Chief Medical and Scientific Officer at the U.S. FDA just weeks after stepping down. His reappointment is reshaping biotech regulatory dynamics and reviving questions about scientific independence under political pressure.
Can real-time blood-volume monitoring finally cut heart failure readmissions?
Discover how FDA-cleared blood-volume monitoring devices like Daxor’s could help hospitals reduce costly heart failure readmissions.
Daxor wins FDA clearance for handheld blood-volume analyzer built with U.S. Department of Defense
Daxor secures FDA clearance for its rapid handheld blood-volume analyzer. Find out how this innovation could reshape heart failure and critical care.
Bristol Myers Squibb Gains U.S. FDA Approval to Remove REMS Programs and Ease Monitoring Rules for Breyanzi and Abecma Cell Therapies
Bristol Myers Squibb gains U.S. FDA approval to remove REMS and reduce monitoring for Breyanzi and Abecma cell therapies, expanding access for blood cancer patients.
NB.1.8.1 triggers COVID crisis in Hong Kong—Global agencies on high alert
NB.1.8.1 variant causes Hong Kong’s worst COVID surge in a year; WHO monitors spread globally as deaths and hospitalizations rise among elderly.
FDA clears Atia Vision’s OmniVu Lens for U.S. clinical trial, signaling a breakthrough in cataract surgery
Atia Vision gets FDA green light to begin U.S. trials of its OmniVu™ Lens, aiming to restore full-range vision post-cataract surgery. See how it may redefine care.
Cybin backs FDA’s call to fast-track psychedelic therapeutics as CYB003 advances in Phase 3 trials
Cybin welcomes FDA’s call to fast-track psychedelics for mental health. See how CYB003 is advancing in Phase 3 trials for depression treatment.
FDA grants orphan drug exclusivity to Mesoblast’s Ryoncil for pediatric SR-aGvHD
Find out how Mesoblast's FDA approval for Ryoncil in pediatric SR-aGvHD sets a new benchmark in stem cell therapy and market exclusivity strategy.
Breakthrough for Wilson disease: Innorna’s IN013 wins dual FDA fast-track approvals
Innorna accelerates mRNA treatment for Wilson Disease with dual FDA designations. Discover how IN013 could transform care for rare genetic disorders!