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

The new device gives adults with hypercholesterolaemia an additional self-administration option for once-monthly Lerochol, while updated prescribing information reflects evidence linking LDL-C reduction with lower cardiovascular event risk.

The Humanitarian Device Exemption provides adults with unresectable, non-metastatic distal bile duct cancer with a new localised radiation option used alongside systemic therapy, although initial US use will be restricted to five centres participating in a post-approval study.

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 Canadian authorisation moves Light AI’s AI-enabled throat-image analysis platform from investigational development into its first regulated market, providing healthcare professionals with a software-based tool to support assessment of suspected Group A Streptococcus infection.

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.

The next-generation sequencing companion diagnostic identifies BRAF V600E and V600K variants, helping clinicians determine which melanoma patients may be eligible for FDA-approved BRAF or BRAF/MEK targeted therapies.

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately.

The engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy.

The approval introduces the first messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults.

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately.

The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.

The biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency.

The expanded indication moves radioligand therapy into an earlier stage of metastatic prostate cancer, providing an additional treatment option for eligible patients before progression to castration-resistant disease.

The updated vaccine is authorised for individuals aged six months and older and aligns the EU COVID-19 vaccination programme with the currently circulating XFG variant.

The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval.

The room-temperature-stable product provides an alternative for adults who require plasma when conventional plasma products are unavailable, including in emergency, remote and austere settings.

The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening.

The approval provides adults and children aged 12 years and older with a single over-the-counter combination option that delivers both rapid and prolonged pain relief without requiring separate analgesic products.

The once-daily treatment introduces the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, with US availability dependent on DEA scheduling.