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New Guideline Issued for Managing Advanced Prostate Cancer

Three major medical organizations have issued recommendations for the diagnosis and treatment of advanced prostate cancer, including metastatic hormone-sensitive disease and nonmetastatic and metastatic castration-resistant disease.
Drugs in the Pipeline

FDA Panel Votes on OTC Nicotine Mouth Spray for Smoking Cessation

The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
Safety Alerts and Recalls

‘Potentially Concerning’ Signal Identified in Long-Term Follow-up Data Involving Paclitaxel-Coated Products

A preliminary analysis of long-term follow-up data (up to 5 years) involving patients with peripheral arterial disease (PAD) treated with paclitaxel-coated products revealed a ‘potentially concerning’ signal of increased long-term mortality when compared with those treated with uncoated devices, according to the Food and Drug Administration (FDA). Among the 3 trials that included 5-year follow-up…

Chantix Labeling Updated Following Pediatric Smoking Cessation Study

Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.