20 articles
Zongertinib and sevabertinib earn FDA accelerated approvals for HER2-mutant NSCLC, expanding targeted therapy options for a historically hard-to-treat subset.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
Sevabertinib and zongertinib win FDA approval for HER2-mutant NSCLC, expanding targeted therapy options for previously treated patients.
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.
The FDA approved zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma, a rare and aggressive bile duct cancer with limited treatment options.
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.
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
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.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
Baxdrostat becomes the first-in-class aldosterone synthase inhibitor approved to treat resistant hypertension alongside existing drugs.
Foundayo (orforglipron) becomes the first oral GLP-1 receptor agonist approved for obesity, offering a pill alternative to injectable Wegovy.
Pembrolizumab plus chemotherapy gains FDA approval for PD-L1-positive ovarian cancer patients who failed prior treatment.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
New GLP-1 drug Foundayo gets fastest FDA approval since 2002, targeting obesity and metabolic health through appetite control.
Orforglipron approved 294 days ahead of schedule for obesity treatment, marking first drug under new priority voucher system.
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
