RedHill Biopharma (RDHL) announced its plan to submit a UK Marketing Authorisation Application for Talicia for treatment of helicobacter pylori infection under the Medicines and Healthcare products Regulatory Agency’s International Recognition Procedure, a fast-track regulatory process for UK drug approvals based on a recognized reference approval. Utilizing the U.S. FDA approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025.
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