North America

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.

A retrospective study of 345 paired tests found 83.5% of patients on RestoreU showed stable or improved cognition over 14 months.

Wandercraft's FDA-cleared Eve exoskeleton offers hands-free upright mobility to wheelchair users with spinal cord injuries at any neurological level.

RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.

Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.

Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid

Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe

The Gaithersburg biotech also secured a $30m Series A extension and won FDA IND acceptance for RPT1G in solid tumours.

A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.

Seer's Proteograph Product Suite has featured in over 100 peer-reviewed studies, spanning disease biology, ageing and population-scale biomarker discovery.

Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.

Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR

X-Chem beat 25 competing teams to become the first to bind Brachyury below 1 micromolar, validating its DEL-based Chemomics platform against a long

Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.

BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.

Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.

The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.

The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.

Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.