Clinical Trials

Pharmaceuticals
Biologics

Rezera launches REVEAL-PAD study to map inflammation in PAD

The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
Pharmaceuticals
Regulatory Science

Syneos Health and Tufts CSDD study finds no superior CRO model

A benchmarking study across 133 trials found operating model design, not outsourcing choice, drives clinical development performance.
A benchmarking study across 133 trials found operating model design, not outsourcing choice, drives clinical development performance.
Biologics
Pharmaceuticals

Tiziana Life Sciences signs KAIMRC MOU for RRMS combination trial

Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
Biologics
Pharmaceuticals
Diagnostics

VivoSim Labs presents NAMkind toxicity data at EUROTOX 2026

VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
Pharmaceuticals

BlossomHill raises $168m IPO and wins FDA Fast Track for BH-30643

BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
Biologics
Pharmaceuticals

J&J's teclistamab wins CHMP backing for second-line myeloma use

The EMA's medicines committee has recommended expanding teclistamab's label to relapsed/refractory myeloma patients after just one prior therapy.
The EMA's medicines committee has recommended expanding teclistamab's label to relapsed/refractory myeloma patients after just one prior therapy.
Biologics
Pharmaceuticals

Roche's Ocrevus gets CHMP backing for paediatric MS

The EMA's medicines committee has recommended ocrelizumab for children aged 10 and over with relapsing MS, following Phase III superiority data over fingolimod.
The EMA's medicines committee has recommended ocrelizumab for children aged 10 and over with relapsing MS, following Phase III superiority data over fingolimod.
Diagnostics
Medical Devices

Conavi Medical publishes hybrid IVUS-OCT case report in CCI

A peer-reviewed case report in Catheterization and Cardiovascular Interventions shows hybrid IVUS-OCT imaging identified post-stent dissections and thrombus missed by
A peer-reviewed case report in Catheterization and Cardiovascular Interventions shows hybrid IVUS-OCT imaging identified post-stent dissections and thrombus missed by
Biologics
Pharmaceuticals

Electra Therapeutics prices upsized $350m IPO on Nasdaq

The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
Pharmaceuticals
Regulatory Science

MIRA Pharmaceuticals submits Ketamir-2 Phase 2a protocol for CIPN

MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
Biologics
Pharmaceuticals

Novartis secukinumab gets positive CHMP opinion for PMR

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
Biologics
Pharmaceuticals
Regulatory Science

Novo Nordisk's Sogroya wins CHMP backing for idiopathic short stature

A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
Pharmaceuticals
Biologics

Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Medical Devices

Treace Medical reports 5-year Lapiplasty data at AOFAS 2026

Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
Pharmaceuticals
Biologics
Regulatory Science

Zealand Pharma gets CHMP nod for glepaglutide in short bowel syndrome

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
Biologics
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Pharmaceuticals
Regulatory Science

Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor to present 24-month Deramiocel DMD data at WMS 2026

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Biologics
Pharmaceuticals

Lisata Therapeutics acquires Marea and raises $225m in concurrent PIPE

Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Biologics
Pharmaceuticals

Novo Nordisk wins CHMP nod for denecimig in haemophilia A

The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
Subscribe to Clinical Trials