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FDA Approves First Oral GLP-1 Weight Loss Pill Orforglipron
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.

Arzneimittelzulassung
9. Mai 2026 0
Four Neurology Drug Approvals Reshaping Brain Disease Treatment
Brain Health

Four Neurology Drug Approvals Reshaping Brain Disease Treatment

From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.

Arzneimittelzulassung
8. Mai 2026 0
FDA Grants Expanded Approval to Zongertinib for HER2-Mutant Lung Cancer
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.

Arzneimittelzulassung
6. Mai 2026 0
FDA Approves Four Neurological Drugs Targeting Alzheimer's, Glioma, and Rare Disease
Brain Health

FDA Approves Four Neurological Drugs Targeting Alzheimer's, Glioma, and Rare Disease

A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.

Arzneimittelzulassung
5. Mai 2026 0
FDA Approves Zongertinib for HER2-Mutant Non-Small Cell Lung Cancer
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.

Arzneimittelzulassung
1. Mai 2026 0
FDA Approves First Drug to Treat Neurologic Complications of Hunter Syndrome
Brain Health

FDA Approves First Drug to Treat Neurologic Complications of Hunter Syndrome

Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.

Arzneimittelzulassung
28. Apr. 2026 0
FDA Greenlights Two New HER2-Targeted Lung Cancer Drugs in Recent Months
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.

Arzneimittelzulassung
28. Apr. 2026 0
Spinraza Gets Higher-Dose Approval to Boost Brain Fluid Exposure in SMA
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.

Arzneimittelzulassung
26. Apr. 2026 0
Orforglipron Oral GLP-1 Pill Approved as Obesity Pipeline Heats Up
Metabolic Health

Orforglipron Oral GLP-1 Pill Approved as Obesity Pipeline Heats Up

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.

Arzneimittelzulassung
21. Apr. 2026 0
FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer
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.

Arzneimittelzulassung
21. Apr. 2026 0
FDA Approves Keytruda Combo for Platinum-Resistant Ovarian Cancer
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.

Arzneimittelzulassung
20. Apr. 2026 0
FDA Approves Zongertinib for HER2-Mutant Lung Cancer in Landmark Targeted Therapy Win
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.

Arzneimittelzulassung
20. Apr. 2026 0
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