North America

Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year

A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.

MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.

The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.

Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1

Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing

ViroMissile's Safety Review Committee has cleared IDOV-2 to advance to a higher dose cohort, with one patient showing confirmed stable disease at six

Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.

Wandercraft's all-cash deal for Ekso Bionics creates a combined portfolio of four medical exoskeletons across rehabilitation and personal mobility markets.

Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.

AI-enabled digital pathology shows aglatimagene drove sustained lymphocyte-tumour engagement more than two years after treatment in a phase 3 prostate cancer trial.

Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU

Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.

PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.

Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.