USFDA

The U.S. Food and Drug Administration (FDA) has announced a Class I recall, its most serious recall category, for certain Medtronic Harmony™ Delivery Catheter Systems (DCS) used to implant transcatheter pulmonary valves. The recall follows concerns that a manufacturing defect could cause the catheter's distal tip to detach during implantation, potentially leading to serious complications, including emergency surgery or death.

The U.S. Food and Drug Administration (FDA) has approved the first at-home starting dose for an Alzheimer's disease treatment, marking a significant advancement in the management of early Alzheimer's disease. The approval allows eligible patients to begin therapy using a subcutaneous (under-the-skin) injection at home, either by self-administration or with the assistance of a caregiver, reducing the need for hospital or infusion-center visits.

The U.S. Food and Drug Administration (FDA) has proposed a major overhaul of its drug establishment registration and drug listing regulations, aiming to modernize oversight of pharmaceutical manufacturing and improve visibility across global supply chains. If finalized, the rule would introduce a new regulatory framework for distributed manufacturing and expand registration requirements for certain foreign drug manufacturing establishments that currently fall outside existing regulations.

The U.S. Food and Drug Administration (FDA) has issued a Letter to Lundbeck Seattle Biopharmaceuticals, alleging that promotional materials for its migraine treatment Vyepti (eptinezumab-jjmr) contained false or misleading claims that overstated the drug's benefits.

The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria (excess protein in the urine) in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval provides a new treatment option for patients with this rare kidney disease, which can eventually lead to kidney failure.

Vertex Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of CASGEVY (exagamglogene autotemcel), allowing its use in children 2 years of age and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises (VOCs) and transfusion-dependent beta thalassemia (TDT). The therapy was previously approved only for patients aged 12 years and older.

The U.S. Food and Drug Administration (FDA) has approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.

The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.