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FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar

February 18th 2025

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

FDA Approves Second Biosimilars for Prolia/Xgeva
FDA Approves Second Biosimilars for Prolia/Xgeva

February 17th 2025

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FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults

February 14th 2025

FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit

February 13th 2025

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FDA Sets Review Date for Linvoseltamab for Multiple Myeloma

February 11th 2025

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