First Likely Vaping Death Reported in US
An Illinois resident who had recently vaped and was hospitalized with severe respiratory illness has died. News Alerts
News Alert
‘Alarming’ First Vaping Death Reported in US
An Illinois resident who had recently vaped and was hospitalized with severe respiratory illness has died. News Alerts
FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR
The class I recall of the transcatheter aortic valve replacement (TAVR) device follows an urgent field warning about burst balloons issued last month by device maker, Edwards Lifesciences. News Alerts
FDA OKs First-in-Class Antibiotic Lefamulin (Xenleta) for CABP
The new semisynthetic pleuromutilin antibiotic will be available for oral and IV administration with a short 5- to 7-day course of therapy for community-acquired bacterial pneumonia (CABP). FDA Approvals
FDA Approves Upadacitinib (Rinvoq), New JAK Inhibitor for RA
Upadacitinib is for adults with moderately to severely active rheumatoid arthritis who fail to respond adequately or are intolerant to methotrexate. FDA Approvals
FDA Expands Approval for TAVR Valves to Low-risk Patients
The Sapien 3 and Sapien 3 Ultra and the CoreValve Evolut R and CoreValve Evolut PRO were previously indicated only in patients at intermediate or higher surgical risk. FDA Approvals
FDA Clears First Spinal Tether Device for Idiopathic Scoliosis
The Tether Vertebral Body Tethering System from Zimmer Biomet Spine is intended to treat growing children and adolescents whose spinal curves fail to respond to conservative treatment like external bracing. FDA Approvals
FDA Approves Another Tumor-Agnostic Cancer Drug
Entrectinib is indicated for the treatment of solid tumors expressing NTRK+ in adults and children, and also for the treatment of metastatic, ROS1-positive non-small cell lung cancer FDA Approvals
FDA Okays Pitolisant (Wakix) for Narcolepsy
The FDA has approved pitolisant, a first-in-class, nonscheduled treatment option with a novel mechanism of action for adults with narcolepsy. FDA Approvals
FDA OKs ‘Game Changer’ Pretomanid for Highly Resistant TB
Pretomanid is only the third approved TB drug in 40 years. A pivotal study shows the oral drug regimen has a success rate of 89% and treatment takes 6 months instead of the current 2 years. FDA Approvals
FDA OKs Oral Ferric Maltol for Iron Deficiency in Adults
Accrufer might lessen the need for patients to progress to intravenous iron therapy, leading to a change in the current paradigm for the treatment of iron deficiency anemia, the company said. FDA Approvals
EU Approves Dupixent for Adolescent Eczema
Dupixent (dupilumab) has won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents, Sanofi and Regeneron said. International Approvals
FDA Gives Go-ahead for More Trials of Paclitaxel Devices in PAD
The agency says clinical trials will require ‘informed consent and close safety monitoring,’ but stands firm on its warning about select use of these stents in clinical practice. News Alerts
FDA Class 1 Recall for Abbott’s Ellipse Implantable Defibrillators
The global recall was issued because of a vulnerability in the electronic circuitry that may make the device unable to deliver high-voltage therapy. News Alerts
FDA Approves First Drug for Tenosynovial Giant Cell Tumor
Tenosynovial giant cell tumor is a nonmalignant, rare tumor type that can cause debilitating symptoms and lead to joint replacements and even amputation. FDA Approvals
First Approval for Immunotherapy for Esophageal Cancer
Esophageal cancer has now joined the list of tumor types that can be treated with a checkpoint inhibitor — in this case, with pembrolizumab (Keytruda). FDA Approvals
FDA Approval for Darolutamide in Prostate Cancer
Darolutamine has been approved for use in nonmetastatic castration-resistant prostate cancer. It joins two other antiandrogens, apalutamide and enzalutamide. FDA Approvals
FDA OKs Streamlined Lyme Disease Tests to Aid Earlier Diagnosis
The modified approach for detecting exposure to Borrelia burgdorferi uses two enzyme immunoassays, with no need for Western blot. FDA Approvals
US News Releases Latest Top Hospitals List
Mayo Clinic is still number 1, and for the 4th straight year, MD Anderson CC is tops in cancer, Cleveland Clinic is tops in cardiology, and the Hospital for Special Surgery is number 1 in orthopedics. Medscape Medical News