Disease

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.

The MAPKeeper 301 trial will test atebimetinib plus modified chemotherapy in first-line metastatic PDAC, with topline overall survival data expected in mid-2028.

KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.

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.

Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.

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

Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.

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

Phase 1 data for CLN-978 and velinotamig show clinical remissions and complete renal responses in heavily pre-treated autoimmune patients.

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 GPER agonist joins the NIA's Interventions Testing Programme, complementing a separate $22m ARPA-H contract to evaluate healthspan preservation.

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.

Elraglusib will be assessed alongside dinutuximab beta and chemotherapy in relapsed and refractory paediatric neuroblastoma across up to 60 international sites.

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.