ILUVIEN Meets Primary Endpoints in Phase 4 Uveitis Trial at Six Months
ILUVIEN meets primary endpoints in Phase 4 uveitis trial, showing 31% reduction in retinal swelling and 3.6-letter visual acuity...
Mesoblast Completes Enrollment of 300 Patients in Rexlemestrocel-L Back Pain Trial
Mesoblast completes enrollment of 300 patients in its pivotal rexlemestrocel-L chronic low back pain trial, targeting mid-2027 data readout.
FDA Approves LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s
FDA approves LEQEMBI IQLIK subcutaneous injection for early Alzheimer's disease, enabling at-home self-administration without clinic infusions starting late Aug
Lecanemab Subcutaneous Autoinjector Shows Bioequivalent Exposure to IV Form
Lecanemab subcutaneous autoinjector achieves bioequivalent exposure to IV form with 104% ratio, supporting fixed-dose initiation without weight adjustments.
Denecimig shows consistent safety and efficacy across age groups in hemophilia A trial
Denecimig demonstrates consistent safety and efficacy across age groups in hemophilia A trial, with 89% of children achieving zero...
INmune Bio’s XPro Shows Significant Brain Imaging Changes in Early Alzheimer’s Trial
INmune Bio's XPro demonstrates statistically significant changes in white matter and gray matter microstructure at 24 weeks in early...
Fate Therapeutics Gets FDA Clearance for FT839 Autoimmune CAR-T Therapy
Fate Therapeutics receives FDA clearance for FT839 autoimmune CAR-T therapy, a dual-targeted allogeneic cell product designed to treat rheumatoid...
Satellos’ SAT-3247 Shows Muscle Fat Reduction in DMD Adults at Six Months
SAT-3247 showed muscle fat reduction in DMD adults at six months, with participants displaying improved upper limb function and...
Setmelanotide Phase 3 Trial for Hypothalamic Obesity Published in NEJM
Setmelanotide Phase 3 Trial achieves 19.8 percentage-point BMI reduction in hypothalamic obesity, published in NEJM following FDA approval.
FDA Accepts Arcutis ZORYVE Application for Atopic Dermatitis in 3-Month-Old Infants
FDA accepts Arcutis ZORYVE for atopic dermatitis in 3-month-old infants, expanding treatment options for the youngest patients with the...