Diagnostics

Diagnostics

Caribou Biosciences CB-011 shows 83% CR rate in r/r myeloma at EHA

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

Roche's Tecentriq wins FDA Priority Review in stage III colon cancer

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
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
Diagnostics

Kura and Kyowa Kirin report 94% 12-month survival in AML combo trial

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.
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.
Diagnostics
Genomics

OraSure wins FDA clearance for at-home STI urine collection kit

OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
Bioprocessing
Diagnostics

RadioMedix wins FDA approval for generic Ga-68 PSMA-11 PET agent

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.
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.
Diagnostics
Digital Health

Ceribell Clarity AI links seizure burden to neurological outcomes

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
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
Diagnostics

DBV Technologies presents VITESSE subgroup data at EAACI 2026

New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
Diagnostics

Sequel Med Tech twiist AID System cuts HbA1c in type 2 pivotal trial

A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
Diagnostics

Sparrow Pharma Phase 2a data back clofutriben in Type 2 diabetes

Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Diagnostics

Boehringer's survodutide hits Phase III endpoints in obesity and MASLD

Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Diagnostics

Diasome Phase 2b data shows HDV-insulin cuts hypoglycemia in T1D

OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
Diagnostics

Biomea Fusion presents icovamenib diabetes data at ADA 2026

Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
Diagnostics
Digital Health

Senseonics presents real-world Eversense 365 data at ADA 2026

New data from 12,360 sensors show the implantable one-year CGM maintained strong glycaemic control and adherence across both open and closed-loop systems.
New data from 12,360 sensors show the implantable one-year CGM maintained strong glycaemic control and adherence across both open and closed-loop systems.
Diagnostics

Cloudbreak Pharma completes final visits for Phase 3 pterygium trial

Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
Diagnostics
Biotech

ACTG launches Phase 2 trial of dasatinib to shrink HIV reservoir

The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
Diagnostics

Spectral Medical PMX shows sustained mortality benefit at 12 months

Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Diagnostics

BeyondSpring plinabulin triple shows durable NSCLC benefit

Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
Diagnostics
Genomics

Cardiff Oncology: onvansertib hits 72% ORR in RAS-mutated mCRC

Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Diagnostics

CG Oncology: cretostimogene combo shows high CR in NMIBC

Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
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