The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.
View Article and Find Full Text PDFOn June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
View Article and Find Full Text PDFOn April 6, 2011, the U.S. Food and Drug Administration approved vandetanib (Caprelsa tablets; AstraZeneca Pharmaceuticals LP) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease.
View Article and Find Full Text PDFOn April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib tablets (Tarceva®; OSI Pharmaceuticals, Inc.
View Article and Find Full Text PDFPurpose: To describe the U.S. Food and Drug Administration (FDA) review and approval of sorafenib (Nexavar; Bayer Pharmaceuticals Corp.
View Article and Find Full Text PDFBlood-borne neurohormonal signals reflect the intermittent burst-like release of peptides and steroids from neurons, glands and target tissues. Hormones control basic physiological processes, such as growth, metabolism, reproduction and stress-related adaptations. Secreted molecules undergo combined diffusion, advection and irreversible elimination from the circulation.
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