Innovation

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.
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
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.
Regulatory Science

Tris Pharma wins FDA Orphan Drug Designation for TRN-257 in IH

The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
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.
Regulatory Science

Signati Medical wins FDA IDE approval for Separo vasectomy device trial

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.

Fractyl Health: Revita holds 78% of GLP-1 weight loss at one year

One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
Biotech

SynCardia's Emperor TAH completes next-gen preclinical implant series

Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
Diagnostics
Regulatory Science

Disc Medicine RALLY-MF data show broad anemia responses in MF

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Cell & Gene Therapy
Biotech

Legend Biotech reports 100% ORR in Phase 1 in vivo CAR-T NHL trial

LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
Genomics

Ziftomenib triplet shows 87% ORR in venetoclax-naive R/R AML

Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Regulatory Science

J&J nipocalimab meets Phasea 2 primary endpoint in lupus study

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Biotech

JJP Biologics: nebaprubart shows early efficacy in rare LAD trial

Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
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.
Regulatory Science

Candel prostate therapy shows 30% DFS gain in Lancet Oncology

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
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.
Genomics

Artios doses first patient in Phase 2 POLKA trial of ART6043

Artios Pharma has started its randomised Phase 2 POLKA study of Pol-theta inhibitor ART6043 plus olaparib in gBRCA-mutated HER2-negative breast cancer.
Artios Pharma has started its randomised Phase 2 POLKA study of Pol-theta inhibitor ART6043 plus olaparib in gBRCA-mutated HER2-negative breast cancer.
Medical Devices

Anika Therapeutics posts 13% revenue rise as margins recover sharply

The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
Digital Health

Amazon One Medical GLP-1 programme launch reshapes weight-loss market

Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Cell & Gene Therapy

Tempest Therapeutics reports 100% CR rate in dual-targeting CAR-T trials

TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
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