Regulation

Biotech

Patient safety checklist marks 25 years with reform agenda unfinished

Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
Biologics
Pharmaceuticals

AnaptysBio reports Jemperli royalties up 34% as FDA decision looms

AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
Pharmaceuticals
Biologics

J&J wins EC approval for icotrokinra in plaque psoriasis

Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Biologics
Medical Devices

Roche wins EC approval for Susvimo refillable eye implant in nAMD

The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
Biologics
Regulatory Science

Leads Biolabs secures ESMO 2026 LBA slot for EP-NEC pivotal data

Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
Pharmaceuticals
Biologics

NewAmsterdam and Menarini win EC approval for obicetrapib

The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
Pharmaceuticals
Biologics

Novo Nordisk CagriSema beats tirzepatide on weight loss in Phase 3

CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
Medical Devices

Z Optics presents six-month IOL data at ESCRS 2026

Z Optics reported zero halos and strong visual acuity across lighting conditions for its Z+ Virtual Aperture IOL in a 43-patient single-centre study.
Z Optics reported zero halos and strong visual acuity across lighting conditions for its Z+ Virtual Aperture IOL in a 43-patient single-centre study.
Cell & Gene Therapy
Bioprocessing
Biologics

Avaí Bio clears cell bank safety testing for Klotho therapy

Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Pharmaceuticals
Biologics

CDT Equity and QIMA to test tapinarof combos in psoriasis

CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
Biologics
Pharmaceuticals

Cue Biopharma: CUE-221 beats placebo and omalizumab in CSU trial

CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
Medical Devices

Milestone Scientific adds Pain and Spine to CompuFlo Programme

Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
Medical Devices
Digital Health
Diagnostics

Philips wins two ITEA 2026 awards for AI-enabled healthcare projects

Philips-led consortia SYMPHONY and AI FORSchung received ITEA Awards of Excellence for connected clinical AI and fibre-optic data compression.
Philips-led consortia SYMPHONY and AI FORSchung received ITEA Awards of Excellence for connected clinical AI and fibre-optic data compression.
Diagnostics
Digital Health
Medical Devices

Spectral AI showcases DeepView burn diagnostic at SRBC

Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Medical Devices
Biotech

BioStem Technologies secures $40m committed equity facility with Roth

The Nasdaq-listed perinatal tissue allograft maker has agreed a $40 million at-will equity facility with Roth Principal Investments for working capital purposes.
The Nasdaq-listed perinatal tissue allograft maker has agreed a $40 million at-will equity facility with Roth Principal Investments for working capital purposes.
Pharmaceuticals

Cardiff Oncology and NMS settle dispute and expand onvansertib deal

Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
Digital Health
Diagnostics

Ultrahuman merges ring data with medical records via HealthEx

Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
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.
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