Heart Health
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.
Drug Approval
Jun 14, 2026 0
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Metabolic Health
FDA Fast-Tracks New Weight Loss Drug Foundayo Under Priority Program
Orforglipron approved 294 days ahead of schedule for obesity treatment, marking first drug under new priority voucher system.
Drug Approval
Apr 16, 2026 0
Cancer Research
FDA Approves Nivolumab Combination Regimen for Classical Hodgkin Lymphoma
Nivolumab plus standard chemotherapy receives FDA approval for classical Hodgkin lymphoma, expanding immunotherapy's role in blood cancers.
Drug Approval
May 27, 2026 0
Cancer Research
Nivolumab Gets FDA Nod for Classical Hodgkin Lymphoma in 2025 Drug Approval Wave
MSK-led research drove 10 FDA cancer drug approvals in 2025, including nivolumab combined with chemotherapy for classical Hodgkin lymphoma.
Drug Approval
May 26, 2026 0
Cancer Research
FDA Approves Nivolumab Combo for Classical Hodgkin Lymphoma
Nivolumab added to standard chemotherapy wins FDA approval, offering a new frontline option for classical Hodgkin lymphoma patients.
Drug Approval
May 26, 2026 0
Brain Health
FDA Approves Leucovorin for Cerebral Folate Deficiency Caused by FOLR1 Variants
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
Drug Approval
May 31, 2026 0
Cancer Research
FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer
Zongertinib (Hernexeos) wins FDA accelerated approval for HER2-driven non-small cell lung cancer, offering a targeted oral option.
Drug Approval
Apr 21, 2026 0
Cancer Research
FDA Grants Expanded Approval to Zongertinib for HER2-Mutant Lung Cancer
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
Drug Approval
May 6, 2026 0
Cancer Research
FDA Approves Two New HER2-Targeted Lung Cancer Drugs in 2025
Sevabertinib and zongertinib win FDA approval for HER2-mutant NSCLC, expanding targeted therapy options for previously treated patients.
Drug Approval
May 24, 2026 0
Metabolic Health
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.
Drug Approval
Apr 6, 2026 0
Cancer Research
FDA Greenlights Two New HER2-Targeted Lung Cancer Drugs in Recent Months
Zongertinib and sevabertinib earn FDA accelerated approvals for HER2-mutant NSCLC, expanding targeted therapy options for a historically hard-to-treat subset.
Drug Approval
Apr 28, 2026 0
Cancer Research
FDA Approves Zongertinib for HER2-Mutant Lung Cancer in Landmark Targeted Therapy Win
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
Drug Approval
Apr 20, 2026 0
Cancer Research
FDA Approves Oral AML Therapy for Elderly Patients Unfit for Intensive Chemo
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
Drug Approval
May 22, 2026 0
Cancer Research
FDA Approves Zongertinib for HER2-Mutated Lung Cancer in February 2026
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.
Drug Approval
Apr 15, 2026 0
Metabolic Health
FDA Approves First Oral GLP-1 Weight Loss Pill Orforglipron
Foundayo (orforglipron) becomes the first oral GLP-1 receptor agonist approved for obesity, offering a pill alternative to injectable Wegovy.
Drug Approval
May 9, 2026 0
Brain Health
Spinraza Gets Higher-Dose Approval to Boost Brain Fluid Exposure in SMA
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
Drug Approval
Apr 26, 2026 0
Metabolic Health
FDA Approves Two New Weight Loss Drugs in Record Two-Week Span
Foundayo and Zepbound receive rapid FDA approval for chronic weight management in adults with obesity or weight-related conditions.
Drug Approval
Apr 5, 2026 0
Cancer Research
FDA Approves Keytruda Combo for Platinum-Resistant Ovarian Cancer
Pembrolizumab plus chemotherapy gains FDA approval for PD-L1-positive ovarian cancer patients who failed prior treatment.
Drug Approval
Apr 20, 2026 0
Cancer Research
FDA Approves Zongertinib for HER2-Mutant Non-Small Cell Lung Cancer
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
Drug Approval
May 1, 2026 0
Cancer Research
MSK Research Drives 11 FDA Cancer Drug Approvals in 2025
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
Drug Approval
May 19, 2026 0
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