FDA Clears AI-Powered Wearable for Essential Tremor
The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations in adults with essential tremor, device maker Fasikl announced. The noninvasive, wearable peripheral nerve stimulator connects to a cloud-based AI platform and incorporates patient recordings to continuously adjust settings, allowing therapy to be personalized. Essential tremor is one of the […]
FDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive, Johnson & Johnson announced Wednesday. Nipocalimab is designed to block the immunoglobulin G (IgG) binding site on the neonatal Fc receptor (FcRn) to reduce […]
FDA OKs Injectable Antibiotic for Three Different Uses
The FDA approved the injectable drug ceftobiprole medocaril sodium (Zevtera) to treat adults with Staphylococcus aureus bacteremia (SAB), the agency announced Wednesday. The antibiotic prodrug is indicated for people with right-sided infective endocarditis, those with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients 3 months to less than 18 years […]
Novel Drug Approved for All Duchenne Muscular Dystrophy Variants
The FDA approved oral givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD) in patients ages 6 years and older, the agency announced Thursday. Givinostat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle. It’s the first nonsteroidal drug approved for patients with all genetic variants of DMD, […]
Pediatric Neuron Disease Gets Its First Gene Therapy
The FDA approved atidarsagene autotemcel (arsa-cel; Lenmeldy), the first gene therapy to treat children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD), the agency announced on Monday. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” Peter Marks, MD, PhD, director of […]
FDA Approves New Agent for Nerve Pain From Rare Inherited Disease
Eplontersen (Wainua) was approved by the FDA to treat polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTR) in adults, Ionis Pharmaceuticals and AstraZeneca announced on Thursday. Hereditary ATTR is caused by a mutation in the TTR gene that results in the buildup of misfolded transthyretin protein, leading to amyloid deposits in the peripheral nerves (ATTR-PN) or […]
MedPAC Draft Recommendation Calls for 1.3% Pay Bump for Medicare Clinicians
Physicians who treat Medicare patients would get about a 1.3% pay increase in 2025 under a draft chairman’s recommendation released Thursday by the Medicare Payment Advisory Commission (MedPAC). That figure represents half of the projected 2.6% increase in the Medicare Economic Index (MEI), a measure of the costs of running a medical practice, Brian O’Donnell, […]
House Members Mull Bills to Cut Red Tape and Improve Docs’ Medicare Pay
A House hearing on ways to increase payments and cut red tape for physicians who treat Medicare patients also included a discussion over whether Republicans wanted to cut Medicare benefits for seniors. “Just yesterday, in a speech on the House floor nominating [Rep.] Jim Jordan (R-Ohio) as their candidate for Speaker, Republicans expressed concern with […]
FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence
The FDA has granted a de novo marketing request for the Revi System for tibial neuromodulation to treat urinary incontinence with or without urinary urgency, BlueWind Medical announced on Thursday. The de novo request allows for treatment of men and women with urge urinary incontinence (UUI). Clinicians should follow applicable clinical guidelines and use professional […]
A Game-Changing Pill For Postpartum Depression Was Just Approved By The FDA
Feinstein Institute A photo of zuranolone, the first pill designed to treat postpartum depression, from its phase 3 clinical trial. The Food and Drug Administration on Friday approved the first-ever pill specifically designed to treat postpartum depression. Taken once a day for two weeks, the drug, called zuranolone and marketed as Zurzuvae, can rapidly and […]