From the first at-home human papillomavirus test and a biosimilar approved for broad immunologic indications, to new options in mitral valve replacement, chronic obstructive pulmonary disease care, and Alzheimer’s diagnostics, May’s U.S. Food and Drug Administration decisions spanned cardiology, pulmonology, neurology, and more. Here’s a comprehensive overview of the month’s most key decisions.
Cardiology
FDA Approves TAVR System for Asymptomatic Aortic Stenosis
The U.S. Food and Drug Administration (FDA) approved the SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform among patients with asymptomatic severe aortic stenosis, marking the first such approval for this population. The decision was based on results from the EARLY TAVR trial, which showed that early intervention significantly reduced the composite risk of mortality, stroke, or unplanned cardiovascular hospitalization compared with clinical surveillance (26.8% vs 45.3%) over a median follow-up of 3.8 years. Devices included in the approval were SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA.
Source: Edwards Lifesciences
Minimally Invasive Option Approved for Mitral Annular Calcification
The FDA approved Abbott’s Tendyne system for patients with severe mitral annular calcification who aren't candidates for open-heart surgery. The transcatheter mitral valve replacement device is self-expanding, repositionable, and retrievable, and is delivered through a small chest incision. Tendyne was designed to accommodate complex mitral anatomies and allows for intraprocedural adjustments to optimize valve function. This approval provides a minimally invasive treatment option for a high-risk population with limited alternatives.
Source: Abbott
Dermatology
Ustekinumab Biosimilar Granted Interchangeability Status
The FDA approved Selarsdi (ustekinumab-aekn), an interchangeable biosimilar to Stelara (ustekinumab), for all approved indications, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients aged 6 years and older as well as moderately to severely active Crohn’s disease and ulcerative colitis in adult patients. The biosimilar, developed through a partnership between Alvotech and Teva Pharmaceuticals, is a human monoclonal antibody targeting the p40 subunit shared by interleukin (IL)-12 and IL-23, produced using Sp2/0 cells and a continuous perfusion process, aligning with the manufacturing approach for the reference biologic. Interchangeability applies to all approved formulations, including subcutaneous and intravenous presentations, allowing broader access across approved indications.
Source: Teva Pharmaceuticals
Gastroenterology
FDA Approves PD-1–Targeted Monoclonal Antibody for SCAC
The FDA approved retifanlimab-dlwr (Zynyz) for first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal in combination with carboplatin and paclitaxel. The PD-1–targeted monoclonal antibody also received approval as monotherapy among patients with disease progression on or intolerance to platinum-based chemotherapy. In the phase III POD1UM-303/InterAACT2 trial, combination therapy reduced the risk of disease progression or mortality by 37%. Common serious adverse events included infections, abdominal pain, anemia, and pulmonary embolism.
Source: Incyte
Neurology
FDA Clears AI Software Upgrade for Portable MRI
The FDA has cleared Optive AI, a tenth-generation software upgrade for Hyperfine’s Swoop Portable MRI system, designed to enhance brain imaging quality across all age groups. The artificial intelligence–powered software optimizes multiple phases of the imaging pipeline—including noise cancellation, acquisition, reconstruction, and postprocessing—to improve image clarity, uniformity, and anatomical detail. Preliminary clinical deployments reported image quality approaching that of conventional 1.5-tesla magnetic resonance imaging systems, suggesting potential for improved diagnostic confidence in point-of-care settings.
Source: Hyperfine
FDA Clears First Blood Test for Alzheimer’s Disease
The FDA has cleared the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test as the first blood-based diagnostic tool to assist in detecting Alzheimer’s disease. Intended for adult patients aged 55 years and older exhibiting signs of cognitive decline, the test measures plasma levels of phosphorylated tau 217 and beta-amyloid 1-42 proteins, calculating their ratio to assess the likelihood of amyloid plaque presence in the brain—a hallmark of Alzheimer’s disease pathology. This less invasive alternative to positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis demonstrated high accuracy in a clinical study, with 91.7% of positive results and 97.3% of negative results aligning with PET or CSF findings.
Source: FDA
FDA Approves Intranasal DHE for Acute Migraine
The FDA approved dihydroergotamine (DHE) (Atzumi) nasal powder for the acute treatment of migraine with or without aura in adult patients. This novel formulation, developed by Satsuma Pharmaceuticals, utilizes the Simple MucoAdhesive Release Technology platform to deliver DHE via a proprietary intranasal device. Clinical trials demonstrated that the DHE nasal powder achieved rapid absorption and sustained plasma concentrations of DHE with low interpatient variability. The most common adverse events (incidence > 1%) included rhinitis, nausea, altered taste, local application site reactions, dizziness, somnolence, pharyngitis, vomiting, and diarrhea.
Source: Satsuma Pharmaceuticals
ObGyn
FDA Clears First At-Home HPV Test
The FDA cleared the Teal Wand, the first at-home self-collection device for cervical cancer screening, for women aged 25 to 65 years. Developed by Teal Health, the device allows users to collect vaginal samples at home, which are then mailed to a certified laboratory for analysis. In a study involving over 600 women, self-collected samples demonstrated noninferiority compared with clinician-collected specimens. The Teal Wand detected high-risk human papillomavirus, the primary cause of cervical cancer. The at-home device may serve as an alternative to in-office Papanicolaou tests for cervical cancer screening.
Source: Teal Health
Pulmonology
FDA Approves Mepolizumab for Eosinophilic COPD
The FDA approved mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The IL-5–targeting monoclonal antibody demonstrated a significant reduction in moderate or severe exacerbations in the phase III MATINEE and METREX trials. Mepolizumab is the first biologic approved for patients with COPD who have blood eosinophil counts as low as 150 cells/μL or more.
Source: GSK Press Release
Radiology
Clinical Trials Missing for Half of AI Tools
The U.S. Food and Drug Administration (FDA) has cleared hundreds of AI-enabled medical devices, yet a recent analysis found that nearly half lacked supporting clinical trial data at the time of approval. Among the 903 AI tools reviewed, just 55.9% included clinical performance evidence, with 24.1% explicitly stating no such studies were conducted. Most devices were intended for radiology use, and few included subgroup-specific outcomes. The findings highlighted ongoing concerns about transparency and the limited role of rigorous clinical evaluation in the regulatory pathway for AI technologies.
Source: JAMA Network Open
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