FDA Alerts

FDA Approval
FDA Approval
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
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
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
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
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
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
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
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
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
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