News
Transcranial Magnetic Stimulation Device Cleared for Smoking Cessation
The outpatient procedure provides noninvasive magnetic stimulation to areas of the brain known to be associated with addiction.
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Drugs in the Pipeline
Novel Therapy for Alzheimer Disease Agitation Gets Breakthrough Designation
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
News
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.
News
FDA Bans Electrical Stimulation Devices for Self-Injurious, Aggressive Behavior
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
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…
News
Nicotine Replacement Products Compared for Smoking Cessation
According to the results of a recent review, the efficacy of nicotine replacement therapy (NRT) in achieving long-term smoking cessation varies based on NRT delivery method, dosage, and timing of initiation.
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…
News
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.
News
Patient’s Black Hairy Tongue Linked to Antibiotic Therapy
The case involved a 55-year-old female patient who had been admitted to the hospital after suffering injuries from a car accident.
Drugs in the Pipeline
Psilocybin Study Gets Green Light From FDA for Treatment-Resistant Depression
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
