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FDA Extends Review Period for GSK’s Blenrep

July 23rd 2025

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com
FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Knee OA

July 18th 2025

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FDA Approves AAVantgarde’s IND Application for Stargardt Gene Therapy

July 17th 2025

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GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

July 14th 2025

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EMA Conditionally Authorizes Stem Cell Therapy for Blood Cancers

June 23rd 2025

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