Pharmaceuticals
Regulatory Science

Teva ecopipam shows durable tic reduction in Tourette trial

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
The Biotech Times Editorial Team  · 
Pharmaceuticals
Digital Health

Discovery Vitality adds doctor-led GLP-1 pathway to weight programme

Discovery Vitality has expanded its HealthyWeight programme to include clinician-assessed access to anti-obesity medicines alongside structured lifestyle support.
Discovery Vitality has expanded its HealthyWeight programme to include clinician-assessed access to anti-obesity medicines alongside structured lifestyle support.
The Biotech Times Editorial Team  · 
Medical Devices

SI-BONE wins FDA 510(k) for iFuse Granite Onyx spinal screw system

SI-BONE's first 510(k)-cleared device outside the pelvis targets screw loosening in spinal fusions for patients with low bone density.
SI-BONE's first 510(k)-cleared device outside the pelvis targets screw loosening in spinal fusions for patients with low bone density.
The Biotech Times Editorial Team  · 
Medical Devices

Wandercraft acquires Ekso Bionics to form global exoskeleton leader

Wandercraft's all-cash deal for Ekso Bionics creates a combined portfolio of four medical exoskeletons across rehabilitation and personal mobility markets.
Wandercraft's all-cash deal for Ekso Bionics creates a combined portfolio of four medical exoskeletons across rehabilitation and personal mobility markets.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Regeneron's trevogrumab preserves muscle during semaglutide weight loss

Phase 2 COURAGE trial data, published in The Lancet, show trevogrumab preserved up to 70% of muscle loss caused by semaglutide in obesity patients.
Phase 2 COURAGE trial data, published in The Lancet, show trevogrumab preserved up to 70% of muscle loss caused by semaglutide in obesity patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roche giredestrant cuts progression risk 44% in breast cancer trial

Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Boehringer's survodutide hits Phase III endpoints in obesity plus T2D

SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Trethera wins FDA Fast Track for TRE-515 in KRAS G12C NSCLC

The Los Angeles biotech secured Fast Track status for its dCK inhibitor paired with KRAS G12C inhibitors in previously treated non-small cell lung cancer.
The Los Angeles biotech secured Fast Track status for its dCK inhibitor paired with KRAS G12C inhibitors in previously treated non-small cell lung cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Monte Rosa MRT-8102 Phase 1 data show ASCVD biomarker normalisation

Monte Rosa's NEK7-directed molecular glue degrader cut key cardiovascular inflammation markers to healthy-volunteer levels in obese, high-risk subjects.
Monte Rosa's NEK7-directed molecular glue degrader cut key cardiovascular inflammation markers to healthy-volunteer levels in obese, high-risk subjects.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Candel Therapeutics publishes Phase 2a NSCLC data showing 24.5-month mOS

Peer-reviewed results for aglatimagene in ICI-refractory NSCLC show median overall survival more than double the docetaxel benchmark.
Peer-reviewed results for aglatimagene in ICI-refractory NSCLC show median overall survival more than double the docetaxel benchmark.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

PolyPid's D-PLEX100 MAA validated by EMA for SSI prevention

The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.
The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Survodutide hits 13.1% weight loss in Phase III obesity-T2D trial

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
The Biotech Times Editorial Team  · 
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