Regulation

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.

Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.

Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.

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.

TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for

Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA

CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.

The deal gives Crystal Crop exclusive India rights to Cibus gene-editing technology targeting higher mustard yields across 8.5 million hectares.

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early

AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.