Teva has secured FDA approval for Weltruza, the first once-monthly subcutaneous extended-release olanzapine injection for adults with schizophrenia.

The FDA has approved Hovilpri, a novel oral helicase-primase inhibitor for refractory mucocutaneous herpes simplex virus infections in immunocompromised adults.

Novartis has secured FDA approval for Rhapsido as the first treatment specifically approved for symptomatic dermographism in adults inadequately controlled by H1 antihistamines.

The FDA has approved Pfizer's Tukysa in combination with trastuzumab and pertuzumab as a first-line maintenance treatment for adults with HER2-positive advanced breast cancer.

The FDA has approved new patient-facing CardioMEMS HF System capabilities that allow people with heart failure to view pulmonary artery pressure readings and receive personalised treatment updates.

The FDA has moved Jaypirca into first-line CLL and SLL treatment following Phase III data showing a substantial reduction in the risk of disease progression or death.

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 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.