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FDA Drug Approvals May 2025

The US FDA New Drug Approvals in May 2025

Shots:     PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025      The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry       The major highlighted drug was AbbVie’s Emrelis securing…

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Abbvie

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots:The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…

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