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Genentech has announced that the Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental New Drug Application (sNDA) for Zelboraf (vemurafenib) in the treatment of Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare and serious blood disease characterized by the abnormal multiplication of...

Novo Nordisk announced that the Food and Drug Administration (FDA)'s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of including data from the LEADER trial in the labeling for Victoza (liraglutide) injection.LEADER was a multi-center, international, randomized, double-blind, placebo-controlled trial that evaluated...

Approximately 32% of drugs approved by the US Food and Drug Administration (FDA) have a newly detected safety issue within 3 years following approval according to a recent study published in the Journal of the American Medical Association (JAMA).The researchers analyzed drugs approved between 2001 and 2010 with a follow-up period through 2017....

www.oncologynurseadvisor.com

 •  February 14

A recently developed drug, already used safely in adult leukemia clinical trials, holds great promise for some children with an aggressive form of cancer known as acute lymphoblastic leukemia (ALL). The findings were published in Blood (2015; doi:10.1182/blood-2014-12-618900). The drug PR-104 was found to be effective against preclinical,...

www.oncologynurseadvisor.com

 •  February 14

A new test is better at detecting aggressive prostate cancer than measuring prostate-specific antigen (PSA) levels. The new test discovers aggressive cancer earlier and reduces the number of false positive tests and unnecessary biopsies. The results were published in The Lancet Oncology (doi:10.1016/S1470-2045(15)00361-7). Prostate cancer is the...