GSK Makes First Tykerb NDA Submission
This article was originally published in The Pink Sheet Daily
Executive Summary
GSK is seeking approval to market lapatinib for the treatment of advanced breast cancer in Herceptin-refractory patients.
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GSK Patient Assistance Program Will Cover Newly Approved Tykerb
Tyrosine kinase inhibitor clears FDA March 13 for use in combination with Roche’s Xeloda for second-line treatment of advanced or metastatic HER2 positive breast cancer.
GSK Patient Assistance Program Will Cover Newly Approved Tykerb
Tyrosine kinase inhibitor clears FDA March 13 for use in combination with Roche’s Xeloda for second-line treatment of advanced or metastatic HER2 positive breast cancer.
EMEA Projects Drug Applications Will Double In 2006
Agency is unclear why applications are up, but notes that, unlike last year, there have been generic and biosimiliar applications.