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ENHERTU wins 10th FDA breakthrough status to target early breast cancer

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have secured their tenth Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration for ENHERTU, marking a pivotal step in moving the blockbuster treatment into earlier, potentially curative stages of breast cancer.

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Incyte wins Japan approval for first dual-targeted lymphoma immunotherapy

Incyte Biosciences Japan G.K. has secured regulatory clearance from Japan’s Ministry of Health, Labour and Welfare for Minjuvi, marking the first time a dual-targeted CD19 and CD20 immunotherapy combination has been authorized for patients with follicular lymphoma in the country.

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Samsung Biologics secures first U.S. production hub in $280M deal with GSK

Samsung Biologics, the world’s leading contract development and manufacturing organization, has reached an agreement to acquire Human Genome Sciences from GSK (NYSE:GSK), marking the South Korean firm’s first physical manufacturing footprint in the United States.

Leia mais: Samsung Biologics secures first U.S. production hub in $280M deal with GSK
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Telix gains momentum as China study hits targets and FDA paths clear

Telix Pharmaceuticals (NASDAQ:TLX) moved closer to expanding its global footprint in precision medicine on Sunday, reporting successful Phase 3 results for its flagship prostate cancer imaging agent in China and clearing regulatory hurdles for its broader pipeline in the United States.

Leia mais: Telix gains momentum as China study hits targets and FDA paths clear