Alfa
FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months
FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval
Bicara’s Ficerafusp Alfa Shows 46% 2-Year Survival Rate for Head and Neck Cancer Subset at ASCO 2025
ASCO 2025; Bicara Therapeutics; ficerafusp alfa; head and neck cancer; PD-L1; overall survival; antibody therapy; Keytruda; tumor shrinkage
Biohaven’s Taldefgrobep Alfa Shifts Focus to Obesity After Missing Primary Endpoint in Spinal Muscular Atrophy Phase 3 Trial
Biohaven, taldefgrobep alfa, spinal muscular atrophy (SMA), obesity, myostatin inhibitor, phase 3 trial, body composition, lean muscle mass, bone density.
Lilly’s Weekly Insulin Candidate Efsitora Alfa Shows Promising Results in Phase III Trials
Eli Lilly, Efsitora Alfa, Weekly Insulin, Type 1 Diabetes, Type 2 Diabetes, Phase III Trials, QWINT Studies, Diabetes Treatment
Lilly’s Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Four Phase 3 Trials
Eli Lilly, efsitora alfa, once-weekly insulin, diabetes management, Phase 3 trials, non-inferiority, A1C reduction, insulin therapy.
Eli Lilly’s Weekly Insulin Efsitora Alfa Shows Promising Results in Late-Stage Trials
Eli Lilly, weekly insulin, efsitora alfa, type 2 diabetes, Phase III trials, QWINT-1, QWINT-3, insulin therapy, diabetes management
BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease
BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms