20 articles
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
Pembrolizumab plus chemotherapy gains FDA approval for PD-L1-positive ovarian cancer patients who failed prior treatment.
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
Tebipenem pivoxil becomes the first oral carbapenem approved in the US, offering a non-IV option for serious UTIs.
Sonrotoclax (Beqalzi), a next-gen BCL-2 inhibitor, wins accelerated FDA approval for relapsed or refractory MCL after BTK inhibitor failure.
Nivolumab plus standard chemotherapy receives FDA approval for classical Hodgkin lymphoma, expanding immunotherapy's role in blood cancers.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
Nivolumab added to standard chemotherapy wins FDA approval, offering a new frontline option for classical Hodgkin lymphoma patients.
Baxdrostat becomes the first-in-class aldosterone synthase inhibitor approved to treat resistant hypertension alongside existing drugs.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
MSK-led research drove 10 FDA cancer drug approvals in 2025, including nivolumab combined with chemotherapy for classical Hodgkin lymphoma.
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
Zongertinib and sevabertinib earn FDA accelerated approvals for HER2-mutant NSCLC, expanding targeted therapy options for a historically hard-to-treat subset.
