dosing
Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients
Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases
FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk
FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6
FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE
Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection
Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost
Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
FDA Approves Extended Dosing for Astellas’ Izervay, Intensifying Competition in Geographic Atrophy Treatment
Izervay, Astellas, FDA approval, extended dosing, geographic atrophy, age-related macular degeneration, Syfovre, Apellis, eye treatment
FDA Approves Extended Dosing for Astellas’ Izervay in Geographic Atrophy Treatment
Izervay, avacincaptad pegol, geographic atrophy, age-related macular degeneration, FDA approval, extended dosing, Astellas Pharma
Eisai Anticipates Growth Acceleration for Alzheimer’s Drug Leqembi Despite Slow Initial Uptake
Leqembi, Alzheimer’s disease, Eisai, expansion phase, sales growth, diagnostics, maintenance dosing, patient adoption
FDA Approves Monthly Maintenance Dosing for Eisai and Biogen’s Alzheimer’s Drug Leqembi
Leqembi, Alzheimer’s disease, FDA approval, monthly maintenance dosing, Eisai, Biogen, amyloid-beta, cognitive decline