Regulatory Science

NeOnc secures UAE IND clearance for brain tumour drug NEO212

NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
Regulatory Science

NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
Genomics

NMD Pharma's ignaseclant shows muscle gains in Phase 2a CMT study

Ignaseclant met multiple secondary functional endpoints in 81 CMT patients, with benefits persisting seven days after the 21-day treatment ended.
Ignaseclant met multiple secondary functional endpoints in 81 CMT patients, with benefits persisting seven days after the 21-day treatment ended.
Diagnostics
Bioinformatics

Adaptive Biotechnologies plans to spin out Immune Medicine unit

The Seattle biotech will separate its profitable clonoSEQ MRD diagnostics arm from its AI-driven immune medicine discovery platform by end of 2026.
The Seattle biotech will separate its profitable clonoSEQ MRD diagnostics arm from its AI-driven immune medicine discovery platform by end of 2026.
Diagnostics

Applied Biologics' XWRAP hits wound closure endpoint in CAMPX trial

Updated analyses of the CAMPX randomised trial show XWRAP plus standard care achieved complete wound closure in 31% of diabetic foot ulcer patients versus 18
Updated analyses of the CAMPX randomised trial show XWRAP plus standard care achieved complete wound closure in 31% of diabetic foot ulcer patients versus 18
Diagnostics

Aptose reports 86% response rate in AML triplet therapy trial at EHA

Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult
Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult
Regulatory Science

Cardiawave begins routine EU rollout of Valvosoft aortic stenosis device

The French medtech has treated its first routine patients in France, the Netherlands and Germany with its non-invasive ultrasound device for severe aortic stenosis.
The French medtech has treated its first routine patients in France, the Netherlands and Germany with its non-invasive ultrasound device for severe aortic stenosis.

Context Therapeutics: CTIM-76 hits 29% ORR in ovarian cancer

Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.
Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.
Regulatory Science
Biotech

Cuprina wins FDA 510(k) clearance for MEDIFLY Lucilia cuprina maggots

Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.
Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.
Genomics
Diagnostics

Pharvaris deucrictibant Phase 3 HAE data presented at EAACI 2026

Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.
Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.

Enterome EO2463 hits 74% ORR in iNHL combo cohort at EHA 2026

Interim SIDNEY trial data show durable CD8 T cell responses and a 41% monotherapy ORR in indolent non-Hodgkin lymphoma patients on watchful waiting.
Interim SIDNEY trial data show durable CD8 T cell responses and a 41% monotherapy ORR in indolent non-Hodgkin lymphoma patients on watchful waiting.

Legend Biotech reports 100% ORR for in vivo CAR-T LB2501 in B-NHL

Phase 1 data showed all six patients at the higher dose responded to a single infusion of LB2501, with no lymphodepletion required and no serious
Phase 1 data showed all six patients at the higher dose responded to a single infusion of LB2501, with no lymphodepletion required and no serious
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