South Korea has authorised Jascayd (nerandomilast) for idiopathic pulmonary fibrosis, providing a new national treatment option for patients with progressive lung scarring.

Saudi Arabia has approved Jascayd for adults with idiopathic pulmonary fibrosis following Phase III evidence showing reduced decline in lung function.

The FDA has approved Emcitate as the first treatment for MCT8 deficiency, providing a therapy for the peripheral thyrotoxicosis associated with this ultra-rare genetic disorder.

The approval introduces a selective dopamine D1/D5 receptor partial agonist as a new oral treatment option for adults with Parkinson's disease.

The FDA approval adds an oral ALK2 inhibitor for patients aged 12 years and older with the ultra-rare genetic disorder fibrodysplasia ossificans progressiva.

The FDA has approved Aqneursa as the first treatment specifically indicated for ataxia in adults and children with ataxia-telangiectasia weighing at least 15kg.

Viatris has received Japanese approval for Wakix to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea.

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.