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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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Regulatory Science

BioCardia wins FDA backing for single-trial PMA path for CardiAMP

FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
Biotech

Hengrui and Kailera report ribupatide Phase 2 oral data at ADA 2026

Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
The Biotech Times Editorial Team  · 
Biotech

Zealand Pharma petrelintide hits 10.7% weight loss at 42 weeks

Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Regulatory Science

Gilead and Lakefront close Ouro Medicines deal for $1.675bn

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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