FDA Approves Utebzi for Complicated Urinary Tract Infections Including Pyelonephritis
Tebipenem pivoxil becomes the first oral carbapenem approved in the US, offering a non-IV option for serious UTIs.
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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.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
Baxdrostat becomes the first-in-class aldosterone synthase inhibitor approved to treat resistant hypertension alongside existing drugs.
Myqorzo (aficamten) wins FDA approval for symptomatic obstructive HCM, offering a novel cardiac myosin inhibitor option for patients.
The FDA approved zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma, a rare and aggressive bile duct cancer with limited treatment options.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.
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.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
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.