FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026
FDA Approval
FDA Approval
09/15/2026
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...
09/15/2026