Biologics
Pharmaceuticals

Biogen presents 76-week EMPAVELI kidney data at ASN 2026

Biogen is presenting long-term Phase 3 data on pegcetacoplan and investigational felzartamab across seven kidney disease programmes at ASN Kidney Week.
Biogen is presenting long-term Phase 3 data on pegcetacoplan and investigational felzartamab across seven kidney disease programmes at ASN Kidney Week.
Pharmaceuticals
Biologics

Coultreon's COL-5671 shows mAb-comparable TNFα inhibition in Phase 1

Coultreon Biopharma presented final Phase 1 data on its oral SIK3 inhibitor at UEGW 2026, with Phase 2 psoriasis recruitment set for Q4 2026.
Coultreon Biopharma presented final Phase 1 data on its oral SIK3 inhibitor at UEGW 2026, with Phase 2 psoriasis recruitment set for Q4 2026.
Biologics
Pharmaceuticals

J&J's guselkumab shows 94% clinical remission at three years in Crohn's

Phase 3 GALAXI data and new FUZION fistula results presented at UEG Week 2026 extend the evidence base for guselkumab in Crohn's disease.
Phase 3 GALAXI data and new FUZION fistula results presented at UEG Week 2026 extend the evidence base for guselkumab in Crohn's disease.
Biologics
Pharmaceuticals

Dostarlimab approved in the US for MSI-H/dMMR rectal cancer

GSK's Jemperli becomes the first immunotherapy cleared for locally advanced MSI-H/dMMR rectal cancer, backed by AZUR-1 trial data showing 68% complete
GSK's Jemperli becomes the first immunotherapy cleared for locally advanced MSI-H/dMMR rectal cancer, backed by AZUR-1 trial data showing 68% complete
Medical Devices
Biologics
Pharmaceuticals

Enable Injections wins first Japan approval for enFuse on-body injector

Japan's MHLW has cleared the CirCLIQ injector for Sanofi's isatuximab SC formulation, making it the first anticancer therapy delivered via an on-body
Japan's MHLW has cleared the CirCLIQ injector for Sanofi's isatuximab SC formulation, making it the first anticancer therapy delivered via an on-body
Pharmaceuticals
Biologics
Bioprocessing

Ekalia and Telix strike deal to expand At-211 production in the US

The IBA-Framatome joint venture will use Telix's RLS radiopharmacy network to commission its first US Astatine-211 production unit in Pennsylvania.
The IBA-Framatome joint venture will use Telix's RLS radiopharmacy network to commission its first US Astatine-211 production unit in Pennsylvania.
Pharmaceuticals
Bioprocessing
Biologics

Telix and Ekalia to build astatine-211 supply chain in the US

Telix Pharmaceuticals and the IBA-Framatome joint venture Ekalia will install an alpha-beam cyclotron near Philadelphia to produce scarce astatine-211 for targeted alpha
Telix Pharmaceuticals and the IBA-Framatome joint venture Ekalia will install an alpha-beam cyclotron near Philadelphia to produce scarce astatine-211 for targeted alpha
Medical Devices
Pharmaceuticals

SpyGlass Pharma BIM-IOL shows 37% IOP cut at four-year mark

Four-year first-in-human data show sustained intraocular pressure reduction and 86% of glaucoma patients remaining drop-free after cataract surgery.
Four-year first-in-human data show sustained intraocular pressure reduction and 86% of glaucoma patients remaining drop-free after cataract surgery.
Pharmaceuticals
Biologics

Disc Medicine's bitopertin hits all endpoints in Phase 3 EPP trial

Disc Medicine said its oral GlyT1 inhibitor bitopertin met co-primary and all secondary endpoints in 183 patients with erythropoietic protoporphyria.
Disc Medicine said its oral GlyT1 inhibitor bitopertin met co-primary and all secondary endpoints in 183 patients with erythropoietic protoporphyria.
Pharmaceuticals

Quanta Therapeutics wins FDA Fast Track for KRAS G12D drug QTX3034

Quanta Therapeutics secured FDA Fast Track designation for QTX3034 in KRAS G12D-mutant colorectal cancer ahead of clinical data presented at ESMO 2026.
Quanta Therapeutics secured FDA Fast Track designation for QTX3034 in KRAS G12D-mutant colorectal cancer ahead of clinical data presented at ESMO 2026.
Biologics
Pharmaceuticals

Ethyreal Bio hits proof of mechanism for TSHR antibody ETHY-001

Phase 1 healthy-volunteer data show potent, durable TSHR engagement from a single dose, as Ethyreal opens patient cohorts in TED and Graves' disease.
Phase 1 healthy-volunteer data show potent, durable TSHR engagement from a single dose, as Ethyreal opens patient cohorts in TED and Graves' disease.
Medical Devices
Regulatory Science

Alpha Tau wins FDA nod to double REGAIN glioblastoma trial size

An IDE supplement expands the REGAIN recurrent glioblastoma trial from 10 to 20 patients, adding survival endpoints and a new interim analysis.
An IDE supplement expands the REGAIN recurrent glioblastoma trial from 10 to 20 patients, adding survival endpoints and a new interim analysis.
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