The FDA has approved the first surgically implanted heart valve designed to be enlarged as a child grows, potentially reducing the need for repeat operations.

The FDA has expanded Camzyos approval to paediatric patients with symptomatic obstructive hypertrophic cardiomyopathy who weigh at least 30kg.

The FDA has approved Gazyva for patients aged two years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission.

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 FDA has approved Teva's DEGEVMA as a biosimilar to Xgeva across all reference-product indications, expanding competition in denosumab treatment.

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

The expanded indication extends Lilly's JAK inhibitor to adolescents aged 12 years and older with severe alopecia areata.

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 EU authorisation introduces a pharmacological treatment for eligible boys with cerebral adrenoleukodystrophy under exceptional circumstances.

The FDA has approved Welireg in combination with Lenvima for adults with advanced clear-cell renal cell carcinoma following prior PD-1 or PD-L1 immunotherapy.

The FDA has approved Lilly's Onswik as a once-weekly basal insulin for adults with type 2 diabetes, reducing the frequency of basal insulin injections from daily to weekly dosing.

The FDA has expanded approval of two Roche HER2 companion diagnostics to identify patients with metastatic gastroesophageal adenocarcinoma who may be eligible for ZIIHERA treatment.

The FDA has approved Lyrfigtu for adults with previously treated FGFR2-altered cholangiocarcinoma, adding a new targeted therapy for this molecularly defined group of bile duct cancers.

The FDA has granted final approval to Lantheus' Bravnetsa for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours.

The European Commission has approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval worldwide for obicetrapib.

The European Commission has authorised Icotyde for adults and adolescents with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Akums has received Indian marketing approval for a fixed treatment kit combining vonoprazan, clarithromycin and amoxicillin for adults with Helicobacter pylori infection.

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

The FDA has approved Cordis' SELUTION SLR sirolimus drug-eluting balloon for treatment of coronary in-stent restenosis, making it the first sirolimus drug-eluting balloon available in the United States.

The FDA has approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on endocrine therapy.