The FDA has approved shorter monitoring requirements following the first two doses of Amgen's Imdelltra, reducing observation time from 22–24 hours to 6–8 hours.

The FDA has expanded the approved use of Ameluz with red-light photodynamic therapy to include treatment of superficial basal cell carcinoma in adults.

The FDA has approved Curium's Bexlutry as the first radioligand equivalent to Lutathera for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours.

The FDA has approved Isembyld as the first spinal muscular atrophy treatment designed to directly target muscle loss, for patients aged 2 years and older receiving an SMN2-targeted therapy.

The FDA has approved Telix's Pixclara as the first FET-PET imaging agent in the United States for evaluating glioma, providing a new tool to help distinguish tumour progression from treatment-related changes.

The FDA has approved Abbott's TactiFlex Duo Ablation Catheter, a dual-energy system combining pulsed-field ablation and radiofrequency energy for the treatment of atrial fibrillation.

The FDA has granted accelerated approval to Etcamah in combination with a CDK4/6 inhibitor for adults with ESR1-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The FDA has approved Zanvastro as the first treatment for Alexander disease in paediatric and adult patients.

The FDA has approved Besremi for adults with essential thrombocythemia, extending ropeginterferon alfa-2b-njft into a second myeloproliferative neoplasm indication in the United States.

Mimrylo is the first FDA-approved polycythemia vera treatment designed to mimic hepcidin, targeting the iron availability that drives excessive red blood cell production.

Priovant’s once-daily JAK/TYK2 inhibitor introduces a new FDA-approved treatment option for the rare autoimmune disease, supported by Phase III evidence of improvements across muscle, skin and physical-function measures.

The once-daily combination of bictegravir and lenacapavir offers virologically suppressed adults a new route to simplify treatment, including patients previously requiring complex multi-tablet regimens.

The updated Comirnaty formulation targets the XFG variant and will begin shipping immediately for eligible older adults and people aged five to 64 at increased risk of severe COVID-19.

The latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly.

The approval introduces the first RAS(ON) inhibitor for previously treated metastatic pancreatic ductal adenocarcinoma with a KRAS G12X mutation, establishing a new biomarker-directed option for one of the hardest-to-treat cancers.

The approvals introduce zanidatamab-based first-line options for adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma, with treatment determined by HER2 status.

The approval extends Johnson & Johnson’s FcRn-blocking therapy into wAIHA, providing a new targeted treatment for adults with a rare autoimmune blood disorder that can cause severe and persistent haemolytic anaemia.

The clearance extends FDA-authorised blood-based assessment of Alzheimer’s-associated amyloid pathology to younger symptomatic adults, providing clinicians with a less invasive alternative to PET imaging and cerebrospinal fluid testing.

The supplemental approval introduces a new self-injection option for patients receiving Yesintek across its approved autoimmune indications without changing the medicine's existing therapeutic uses.

The approval provides clinicians with a dedicated injectable treatment for moderate to severe infraorbital hollowing in adults aged 22 years and older, expanding aesthetic treatment options for the under-eye region.