The FDA has issued final guidance clarifying how prescription drug manufacturers should address companion apps and software in product labelling and regulatory submissions.

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.

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 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 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.

The FDA has approved and Amneal has launched a 120 mg/0.5 mL lanreotide injection referencing Somatuline Depot, expanding competition in the US complex-injectables market.