North America

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.

Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.

Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.

Early data from 15 heavily pretreated patients show robust B-cell depletion and durable platelet responses, with no serious adverse events reported.

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

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

Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.

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

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.

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.

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.

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

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

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death