Regulation

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.

Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.

The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.

Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight

OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.

The Belgian medtech closed a $95m equity round and expects a $15m EIB loan tranche as it scales its FDA-approved Genio neurostimulator commercially.

The Barcelona biotech has dosed its first participants in a 30-patient study of TrkB modulator CTH120, the only compound in late-stage development for

Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.

The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.

RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.

Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2

The Watertown biotech enrolled 191 patients across 14 countries; topline results for the PH-HFpEF candidate are expected in early Q1 2027.

Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of

The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.

Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.

The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.