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FDA Approval

FDA Approval

FDA Expands Joenja Approval to Children Aged 4 to 11 Years With APDS

09/25/2026

Anthony Calabro, MA

Pediatric safety and pharmacokinetic findings supported expanding leniolisib to children aged 4 to 11 years who weigh at least 27 kg, establishing the first FDA-approved treatment for activated...

09/25/2026

FDA Approval

FDA Approval

FDA Expands Hyrnuo Accelerated Approval in HER2-Mutated Advanced Non–Small Cell Lung Cancer

09/23/2026

Anthony Calabro, MA

Results from the SOHO-01 trial supported expanded use of sevabertinib in adults with HER2-mutated, locally advanced or metastatic nonsquamous non–small cell lung cancer, including patients who had not...

09/23/2026

FDA Approval

FDA Approval

FDA Grants Accelerated Approval to Camizestrant Combination for ESR1-Mutated Advanced Breast Cancer

09/18/2026

Anthony Calabro, MA

The FDA approval addresses acquired endocrine resistance by allowing eligible patients with HR-positive, HER2-negative advanced breast cancer to switch to camizestrant when an ESR1 mutation is detected in...

09/18/2026

FDA Approval

FDA Approval

FDA Approves Zanvastro as First Treatment for Alexander Disease

09/16/2026

Anthony Calabro, MA

Clinical and pharmacokinetic evidence supported approval of zilganersen across pediatric and adult age groups, providing the first therapy designed to reduce production of the abnormal GFAP protein...

09/16/2026

FDA Approval

FDA Approval

FDA Approves Isembyld as First Spinal Muscular Atrophy Therapy Targeting Muscle Loss

09/15/2026

Anthony Calabro, MA

A 52-week trial evaluated apitegromab-mstn as an adjunct to SMN2-targeted treatment in patients with spinal muscular atrophy who could not move or walk independently, demonstrating improved motor function...

09/15/2026

October 2026

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October 2026