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.
Tebipenem pivoxil becomes the first oral carbapenem approved in the US, offering a non-IV option for serious UTIs.
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.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
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.
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
Foundayo (orforglipron) becomes the first oral GLP-1 receptor agonist approved for obesity, offering a pill alternative to injectable Wegovy.
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 FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
Sonrotoclax (Beqalzi), a next-gen BCL-2 inhibitor, wins accelerated FDA approval for relapsed or refractory MCL after BTK inhibitor failure.
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.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
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.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.