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The agency’s expanded approval was supported by results from a study, with 24 percent of participants having had at least one cancerous lesion detected. Read More
The FDA has approved updated labeling for Genentech’s Xeloda (capecitabine) tablets with eight new or revised indications — the first drug to get a labeling update under Project Renewal, a pilot program aimed at updating labeling for older oncology drugs. Read More
Alexis Bio and Xeno Therapeutics’ realSKIN, a xenograft cultured from live porcine skin tissue, has become the first non-autologous tissue to win the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation. Read More
Two potentially first-in-class small molecule oral agents induced complete remission in nearly 30 percent of patients with genetically induced leukemias generally associated with very poor prognoses, according to reports from the American Society of Hematology (ASH) Annual Meeting in New Orleans. Read More