Regulatory Science

The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.

The European Commission has expanded lomitapide's indication to children aged five and older with homozygous familial hypercholesterolaemia, backed by Phase 3 data.

FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.

Propensity-score-matched analysis showed potravitug nearly doubled viral clearance rates vs controls in kidney transplant recipients with BK polyomavirus infection.

Orelabrutinib met primary and secondary endpoints in a 187-patient Phase IIb SLE trial, with 57% SRI-4 response versus 34% for placebo at week

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.

Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.

Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.

Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.

Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.

Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.

Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.

ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.

Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.