FDA Panel Gives Thumbs Down to Novel Strategy for Switching Breast Cancer Therapy
A novel strategy for switching breast cancer therapy intrigued members of an FDA advisory committee but failed to sway the panel to recommend approval of the strategy. By a 6-3 vote, the Oncologic Drugs Advisory Committee (ODAC) agreed with an FDA staff assessmentopens in a new tab or window that a randomized trial of the […]
Novel ICD Lead for Conduction System Pacing Enters the Arena
Introducción A dedicated bipolar implantable cardioverter-defibrillator (ICD) lead for conduction system pacing (CSP) performed well in a first-in-human multicenter study. Placement of the novel UltiSynq CSP ICD lead, designed for left bundle branch area (LBBA) pacing, met expectations for safety and effectiveness in over 200 patients with indications for novo ICD or cardiac resynchronization therapy […]
Paging Dr. AI; Myth Busting in Cancer; Oncologists Shine in Malpractice Survey
Artificial Intelligence in Oncology Could the growing influence of artificial intelligence (AI) in healthcare lead to a license to practice oncology? (ASCO AI in Oncology) Informed by an analysis of 2,000 abdominal CT scans, a next-generation AI system helped clinicians identify pancreatic cancer up to 3 years before clinical diagnosis. (Mayo Clinic) Using serial facial […]
Zebra of the Week: OTOF-Related Genetic Deafness (DFNB9)
Introducción Autosomal recessive nonsyndromic hearing loss 9 (DFNB9) is a rare genetic condition caused by mutations in the OTOF gene, which encodes otoferlin. This disorder primarily affects hearing and is inherited in an autosomal recessive pattern, requiring pathogenic variants in both gene copies. Fenotipos clínicos DFNB9 includes two principal clinical phenotypes. The first is prelingual […]
Court Restricts Abortion Access Across U.S. by Blocking the Mailing of Mifepristone
Resumen del caso A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking the mailing of mifepristone prescriptions. The unanimous ruling Friday from a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals requires that the abortion pill be distributed only […]
FDA Takes Steps to Expand Testosterone for Men’s Libido
Introducción Heralding a “step forward on testosterone therapy for men,” the FDA announced an initiative to support a potential new indication of low libido in men due to idiopathic hypogonadism. The FDA will encourage drug companies with existing approved indications for testosterone replacement therapy (TRT) to contact the agency about the potential new indication. “New […]
Novel Agent Reduces Seizures in Treatment-Resistant Epilepsy
Introducción Investigational azetukalner met its primary endpoint of reducing focal onset seizure frequency across two doses, initial findings from the phase III X-TOLE2 trial showed. Over 12 weeks, adjunctive treatment with 25 mg azetukalner led to a 53.2% median decline from baseline in monthly focal onset seizure frequency, compared with a 10.4% drop for placebo […]
Novel KRAS Drug Shows ‘Excellent’ Efficacy in Tough-to-Treat Lung Cancer
San Diego — Investigational zoldonrasib was well tolerated and showed encouraging clinical activity in previously treated KRAS G12D-mutated non-small cell lung cancer (NSCLC), according to a phase I study. Among patients previously treated with an immune checkpoint inhibitor and platinum-based chemotherapy (but not docetaxel), the objective response rate was 52%, with a disease control rate […]
GLP-1 Drug Improved Motivation in Major Depressive Disorder
Treatment with oral semaglutide (Rybelsus) significantly improved motivation measures in patients with major depressive disorder (MDD), according to a secondary analysis of a randomized trial. Among 72 participants with MDD and overweight or obesity, those receiving oral semaglutide 14 mg showed an increased willingness to expend physical effort when higher expected rewards were present (treatment […]
Should Patients Over 75 Undergo Surveillance Colonoscopies?
Colorectal cancer prevention has been framed around a simple principle: find polyps early, remove them, and repeat colonoscopy to prevent cancer down the line. This approach has saved lives. But like many well-intentioned practices in medicine, what works well at one stage of life may offer diminishing, and even negligible, returns at another. Why We […]