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

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 conditional marketing approval introduces a new intravenous abatacept biosimilar for patients with moderate to severe rheumatoid arthritis or active psoriatic arthritis who have responded inadequately to other disease-modifying treatments.

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 MHLW marketing approval adds a Neulasta biosimilar to Biocon’s Japanese portfolio, with Sandoz K.K. responsible for its exclusive promotion, sale and distribution in the country.

The authorisation gives patients aged five years and older the first treatment specifically approved for Rett syndrome across the European Union, with Acadia preparing for an initial German launch in the fourth quarter of 2026.

The approval establishes Trodelvy-based treatment across PD-L1 status in first-line metastatic TNBC in Europe, following the earlier authorisation of Trodelvy monotherapy for patients not eligible for PD-1/PD-L1 inhibitors.

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.

The approval provides clinicians with a new PET imaging agent to identify tau neurofibrillary tangle pathology in adults undergoing assessment for Alzheimer's disease, complementing existing diagnostic tools.

The approval provides adults with fibrodysplasia ossificans progressiva with a new treatment option designed to reduce abnormal bone formation and disease flare-ups in an ultra-rare genetic disorder.

The approval introduces the first therapy designed to address the underlying cause of glycogen storage disease type Ia, offering a one-time gene therapy option for eligible patients aged eight years and older.

The new device provides adults with hypercholesterolaemia with an additional self-administration option for once-monthly Lerochol alongside the existing pre-filled syringe.

The clearance extends Wandercraft’s self-balancing exoskeleton technology beyond supervised rehabilitation, allowing eligible adults with spinal cord injuries to use Eve for hands-free upright mobility and daily activities with a trained companion.

The approval provides adults who have received at least one prior line of therapy with a new iberdomide-based combination, supported by higher minimal residual disease-negative complete response rates than the comparator regimen in EXCALIBER-RRMM.