Regulation

The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.

Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by

Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold

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

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

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.

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

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

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

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

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.

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

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

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

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

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

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

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

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