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Homepage > Company > Media > Pharma News > 2024 > Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

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Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the Center for Drug Evaluation (CDE) of China&...

FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a...

Gilead gives up on $15M MASH bet with Yuhan after mulling preclinical data

Gilead gives up on $15M MASH bet with Yuhan after mulling preclinical data

In a year that has seen an approval and a raft of readouts for metabolic dysfunction-associated steatohepatitis (MASH), Gilead has decided to walk away from a $785 million biobucks deal in the...

FDA AdCom votes in favour of Stealth’s Barth syndrome drug

FDA AdCom votes in favour of Stealth’s Barth syndrome drug

AUS Food and Drug Administration (FDA) advisory committee (AdCom) has voted in support of Stealth BioTherapeutics’ first-line Barth syndrome drug, despite a trial studying the drug n...