North America

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.

New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and

New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.

NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.

The Virginia-based cardiovascular biotech priced 3.75 million shares at $12 each to fund its Phase 2b and planned Phase 3 trials of RTN

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening

Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.

The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.

The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC

The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late

Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.

Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.

Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.

The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.

The New Haven CNS platform company will use the 36-month grant to push its BrainEx system from 24-hour to two-week intact human

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.

The Virginia biotech secured a Project BioShield award to advance its pralidoxime auto-injector through FDA approval and initial stockpile procurement.