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Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024....more

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