BioSpace News Archive

FDA

ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors

AstraZeneca and Daiichi Sankyo’s ENHERTU® has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

April 5, 2024
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34 min read
FDA

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

Daiichi Sankyo and AstraZeneca’s ENHERTU® has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

April 5, 2024
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35 min read
Policy

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Johnson & Johnson announced that the U.S. FDA has approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

April 5, 2024
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30 min read
Policy

Legend Biotech’s CARVYKTI® (ciltacabtagene autoleucel) Becomes the First and Only BCMA-Targeted CAR-T Cell Therapy Approved by the FDA for Second-Line Treatment of Multiple Myeloma

Legend Biotech Corporation announced the U.S. Food and Drug Administration has approved CARVYKTI® for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide.

April 5, 2024
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28 min read
Press Releases

Pantherna and WACKER Intensify Collaboration in the Development and Production of mRNA Biopharmaceuticals

April 5, 2024
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4 min read