2025 ACC/AHA Guideline: Core Competencies for Advanced Cardiovascular Imaging Training

2025 ACC/AHA Guideline: Core Competencies for Advanced Cardiovascular Imaging Training

Advanced cardiovascular imaging plays a pivotal role in diagnosing, risk-stratifying, and managing a spectrum of cardiac conditions, from ischemic heart disease to cardiomyopathies and valvular disorders. However, rapid technological evolution—spanning echocardiography (echo), cardiovascular computed tomography (CCT), cardiovascular magnetic resonance (CMR), and nuclear cardiology—demands rigorous, standardized training to ensure competency and patient safety. The 2025 Advanced Training Statement on Advanced Cardiovascular Imaging, jointly authored by the American College of Cardiology (ACC), American Heart Association (AHA), American Society of Echocardiography (ASE), American Society of Nuclear Cardiology (ASNC), Society of Cardiovascular Computed Tomography (SCCT), and Society for Cardiovascular Magnetic Resonance (SCMR), and issued by the ACC Competency Management Committee, addresses this need by updating prior frameworks to reflect contemporary practice.

FDA Greenlights PADCEV-Keytruda Combo for Cisplatin-Ineligible MIBC Patients

FDA Greenlights PADCEV-Keytruda Combo for Cisplatin-Ineligible MIBC Patients

Muscle-invasive bladder cancer (MIBC) represents approximately 30% of the ~614,000 annual global bladder cancer cases, ranking it as the ninth most common malignancy worldwide. While neoadjuvant cisplatin-based chemotherapy followed by cystectomy remains the standard for eligible patients, up to half of those with MIBC are ineligible for cisplatin due to comorbidities, renal impairment, or other factors, leaving them with limited perioperative options and high recurrence rates—nearly 50% even post-surgery. On November 21, 2025, the U.S. Food and Drug Administration (FDA) approved a transformative regimen: PADCEV® (enfortumab vedotin-ejfv), a Nectin-4-directed antibody-drug conjugate (ADC), in combination with Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), for neoadjuvant treatment followed by adjuvant therapy post-cystectomy in cisplatin-ineligible adults with MIBC.

FDA Expands KOSELUGO Approval: Selumetinib for Adult NF1 Patients

FDA Expands KOSELUGO Approval: Selumetinib for Adult NF1 Patients

Neurofibromatosis type 1 (NF1) is a genetic disorder affecting approximately 1 in 3,000 individuals, characterized by the development of benign tumors, including plexiform neurofibromas (PN)—complex, infiltrative growths that often cause significant morbidity such as pain, disfigurement, functional impairment, and reduced quality of life. In adults, symptomatic, inoperable PN represent a particularly challenging subset, as surgical resection is frequently infeasible due to tumor encasement of vital structures, invasiveness, or vascularity, leaving limited therapeutic options.

FDA Greenlights KYGEVVI®: Historic First Approval for TK2d Across All Ages

FDA Greenlights KYGEVVI®: Historic First Approval for TK2d Across All Ages

On November 4, 2025, Application Therapeutics Inc., a precision medicine company specializing in rare genetic disorders, announced the U.S. Food and Drug Administration (FDA) approval of KYGEVVI® (doxecitine and doxribtimine oral suspension), marking a paradigm shift in the treatment landscape for thymidine kinase 2 deficiency (TK2d). This ultra-rare mitochondrial disease, caused by biallelic mutations in the TK2 gene, impairs mitochondrial DNA synthesis, leading to severe skeletal muscle myopathy, respiratory insufficiency, and often early mortality. Affecting approximately 200-300 patients in the U.S., TK2d has historically lacked disease-modifying therapies, leaving families reliant on supportive care amid relentless progression.