20 articles
The FDA reportedly approved Eli Lilly's orforglipron, a daily oral GLP-1 receptor agonist for obesity, marking a potential shift from injectable weight-loss drugs.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
Foundayo (orforglipron) becomes the first oral GLP-1 receptor agonist approved for obesity, offering a pill alternative to injectable Wegovy.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
Myqorzo (aficamten) wins FDA approval for symptomatic obstructive HCM, offering a novel cardiac myosin inhibitor option for patients.
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
New GLP-1 drug Foundayo gets fastest FDA approval since 2002, targeting obesity and metabolic health through appetite control.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Orforglipron approved 294 days ahead of schedule for obesity treatment, marking first drug under new priority voucher system.
MSK-led research drove 10 FDA cancer drug approvals in 2025, including nivolumab combined with chemotherapy for classical Hodgkin lymphoma.
Nivolumab plus standard chemotherapy receives FDA approval for classical Hodgkin lymphoma, expanding immunotherapy's role in blood cancers.
Sonrotoclax (Beqalzi), a next-gen BCL-2 inhibitor, wins accelerated FDA approval for relapsed or refractory MCL after BTK inhibitor failure.
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
Pembrolizumab plus chemotherapy gains FDA approval for PD-L1-positive ovarian cancer patients who failed prior treatment.
Nivolumab added to standard chemotherapy wins FDA approval, offering a new frontline option for classical Hodgkin lymphoma patients.
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
