FDA actions in Brief
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult and pediatric patients.
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FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic atrophy secondary to age-related macular degeneration.
David Joyner: CVS Health is on a Pharmacy Transformation Journey
Just as Andrew Witty of UnitedHealth Group did in a call with investors last month, CVS Health’s CEO David Joyner defended the role of PBMs in healthcare.
FDA Sets Review Date for Linvoseltamab for Multiple Myeloma
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma is July 10, 2025.
FDA Approves Combination Antibiotic for Complicated Infections
Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
FDA Sets Review Date for Chronic Lung Disease Therapy
Regulators have set a goal of Aug. 12, 2025, for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung disease.
