Biologics
Pharmaceuticals

Biogen publishes Phase 3 EMPAVELI paediatric data in CJASN

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

SNIPR enrolls first Phase 2 patient in CRISPR phage trial

SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
The Biotech Times Editorial Team  · 
Medical Devices

Wandercraft launches Eve self-balancing exoskeleton for home use

Wandercraft's FDA-cleared Eve exoskeleton offers hands-free upright mobility to wheelchair users with spinal cord injuries at any neurological level.
Wandercraft's FDA-cleared Eve exoskeleton offers hands-free upright mobility to wheelchair users with spinal cord injuries at any neurological level.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

uMETHOD Health publishes real-world study on AI dementia care plans

A retrospective study of 345 paired tests found 83.5% of patients on RestoreU showed stable or improved cognition over 14 months.
A retrospective study of 345 paired tests found 83.5% of patients on RestoreU showed stable or improved cognition over 14 months.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals
Regulatory Science
Biologics

Ultragenyx wins FDA approval for FAYUVI in Sanfilippo syndrome Type A

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals

Sol-Gel hits LPLV milestone in Phase 3 Gorlin syndrome trial

Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
The Biotech Times Editorial Team  · 
Biotech
Bioinformatics

Anew Labs raises $290m at $1.5bn valuation for AI drug discovery

ByteDance's AI drug discovery spin-off Anew Labs has closed a reported $290m first external round, led by HSG, IDG Capital and Hillhouse Investment.
ByteDance's AI drug discovery spin-off Anew Labs has closed a reported $290m first external round, led by HSG, IDG Capital and Hillhouse Investment.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

RWS launches Tridion agentic platform for regulated content workflows

RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.
RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

Flow Neuroscience launches FDA-cleared at-home tDCS device FL-100

Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
The Biotech Times Editorial Team  · 
Medical Devices
Biologics
Pharmaceuticals

EIB and Angelini Ventures hit €48.5m deployed under €150m facility

The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
The Biotech Times Editorial Team  · 
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