FDA Approves Foundayo for Weight Loss in Record 50 Days
New GLP-1 drug Foundayo gets fastest FDA approval since 2002, targeting obesity and metabolic health through appetite control.
20 articles
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.
Foundayo and Zepbound receive rapid FDA approval for chronic weight management in adults with obesity or weight-related conditions.
Foundayo (orforglipron) becomes the first oral GLP-1 receptor agonist approved for obesity, offering a pill alternative to injectable Wegovy.
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.
FDA approves Foundayo (orforglipron) and Zepbound (tirzepatide) for chronic weight management in adults with obesity or overweight conditions.
Myqorzo (aficamten) wins FDA approval for symptomatic obstructive HCM, offering a novel cardiac myosin inhibitor option for patients.
Baxdrostat becomes the first-in-class aldosterone synthase inhibitor approved to treat resistant hypertension alongside existing drugs.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
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.
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
Sonrotoclax (Beqalzi), a next-gen BCL-2 inhibitor, wins accelerated FDA approval for relapsed or refractory MCL after BTK inhibitor failure.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.