FDA Approves Aficamten for Obstructive Hypertrophic Cardiomyopathy
Myqorzo (aficamten) wins FDA approval for symptomatic obstructive HCM, offering a novel cardiac myosin inhibitor option for patients.
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Myqorzo (aficamten) wins FDA approval for symptomatic obstructive HCM, offering a novel cardiac myosin inhibitor option for patients.
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
Zongertinib and sevabertinib earn FDA accelerated approvals for HER2-mutant NSCLC, expanding targeted therapy options for a historically hard-to-treat subset.
Baxdrostat becomes the first-in-class aldosterone synthase inhibitor approved to treat resistant hypertension alongside existing drugs.
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
Sevabertinib and zongertinib win FDA approval for HER2-mutant NSCLC, expanding targeted therapy options for previously treated patients.
Foundayo and Zepbound receive rapid FDA approval for chronic weight management in adults with obesity or weight-related conditions.
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.
Orforglipron approved 294 days ahead of schedule for obesity treatment, marking first drug under new priority voucher system.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Tebipenem pivoxil becomes the first oral carbapenem approved in the US, offering a non-IV option for serious UTIs.
The FDA approved zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma, a rare and aggressive bile duct cancer with limited treatment options.