The FDA has approved satralizumab for adults with thyroid eye disease, introducing the first at-home subcutaneous treatment option. The decision follows two Phase 3 trials, one of which missed its primary endpoint, while the other demonstrated significant improvements in eye bulging and double vision.
A peer-reviewed five-year indirect comparison associates BRIUMVI with lower modeled disability progression risk than ocrelizumab and ofatumumab. The findings support TG Therapeutics' commercial evidence strategy but cannot establish head-to-head superiority.
Bristol Myers Squibb's admilparant meets Phase 3 IPF endpoint at 60 mg, but 120 mg misses. Examine efficacy, safety and FDA prospects.
Genentech's vamikibart sustained vision gains at 52 weeks, but mixed Phase III results leave questions ahead of a July 2027 FDA decision.
Roche’s sefaxersen hits its Phase III IgAN endpoint with significant proteinuria reduction. See what the result means for regulators and competitors.
The European Commission has approved Roche’s Susvimo implant for neovascular age-related macular degeneration, offering continuous ranibizumab delivery with refills every six months and creating a fundamentally different alternative to repeated eye injections.
Roche has secured FDA Priority Review for Enspryng in myelin oligodendrocyte glycoprotein antibody-associated disease after Phase 3 data showed a 68% reduction in relapse risk versus placebo.
Remibrutinib wins two Phase III multiple sclerosis trials as Novartis prepares global filings. See what the results mean for the BTK race.
Roche has secured FDA clearance for Elecsys pTau217, a single-biomarker blood test capable of supporting both rule-in and rule-out assessment of Alzheimer’s-associated amyloid pathology across primary and specialty care.
Roche has secured expanded FDA approval for two HER2 companion diagnostics used to identify gastroesophageal adenocarcinoma patients who may be eligible for Jazz Pharmaceuticals’ ZIIHERA.