Amgen’s Tepezza is facing a broader thyroid eye disease treatment landscape after Viridian Therapeutics’ Lumvoa became another approved option, shifting attention toward how physicians may weigh evidence, safety, treatment burden and patient fit. Dr. Raymond Douglas, MD, PhD, who served as principal investigator in the international Tepezza trials that supported its United States Food and
ForSight Robotics expands JASPER cataract surgery experience to 26 patients, testing whether robotic eye surgery can fit routine clinical workflow.
IPS HEART gains FDA rare pediatric designation for ISX9-CPC, but the iPSC heart therapy remains preclinical as human testing becomes the key hurdle.
Kardium wins Health Canada approval for the Globe Pulsed Field System, extending its integrated atrial fibrillation platform beyond the U.S.
Energenesis and Taiwan Tanabe advance ENERGI-F703DFU development as the Phase III diabetic foot ulcer program moves toward a Taiwan NDA.
Northwest Biotherapeutics and SPIMACO target a Saudi DCVax-L pathway. See what the MOU means for approval and local manufacturing.
Australian medical robotics company Vexev has raised $6 million to support FDA regulatory work, manufacturing scale-up and U.S. commercialization of VxWave after a multicenter study showed that dialysis-clinic staff could perform semi-autonomous vascular scans with the investigational system.
Senhwa Biosciences has secured Taiwan regulatory clearance for a multicenter Phase 1b/2a trial combining pidnarulex, or CX-5461, with BeOne Medicines’ PD-1 inhibitor tislelizumab in advanced solid tumors. The study will test whether DNA replication stress can make immunologically cold or checkpoint-resistant cancers more responsive to immunotherapy.
Takeda Pharmaceutical Company Limited has secured United States Food and Drug Administration approval for ORZEYFUL, or oveporexton, the first oral orexin receptor 2 agonist authorised to treat narcolepsy type 1 as a complete disorder in adults. The approval introduces a new treatment mechanism, but the medicine will not become available until the Drug Enforcement Administration
KKR’s €1.2 billion Medicover India deal targets a 24-hospital platform as private capital accelerates India’s healthcare consolidation.