Regulation

Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.

VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.

BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.

The EMA's medicines committee has recommended expanding teclistamab's label to relapsed/refractory myeloma patients after just one prior therapy.

The EMA's medicines committee has recommended ocrelizumab for children aged 10 and over with relapsing MS, following Phase III superiority data over fingolimod.

MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.

A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.

The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.

The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.

Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.

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

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.