Disease

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  · 
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
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  · 
Pharmaceuticals
Biologics

Ascendis Pharma to regain TransCon rights in metabolic diseases

Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
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  · 
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  · 
Digital Health
Medical Devices

NightWare wearable cuts nightmare distress in first responder study

A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Senseonics partners Beta Bionics to link Eversense 365 with iLet

Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.
Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.
The Biotech Times Editorial Team  · 
Genomics
Diagnostics

Bionano OGM detects hidden genomic risk in MDS and AML studies

Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

BioVie's bezisterim hits subgroup endpoints in Phase 2 Long COVID trial

BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Connect Biopharma's rademikibart cuts asthma treatment failure by 66%

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Dogwood Therapeutics completes enrolment in Halneuron CINP Phase 2b

The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Elevar Therapeutics files EMA application for lirafugratinib in CCA

Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

ENA Respiratory begins Part B dosing in INNA-051 Phase IIa study

The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

One04 Therapeutics launches on Phase 1 data for Factor H candidate

The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio wins FDA Priority Review for SkinTE BLA in DFUs

The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Vera Therapeutics' TRUTAKNA cuts IgAN progression risk 76% in Phase 3

Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Agomab reports positive Phase 1 data for inhaled IPF drug AGMB-447

Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Curium wins FDA approval for BEXLUTRY lutetium RLT in GEP-NETs

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Pharmazz wins FDA Orphan Drug Designation for sovateltide in NHIE

Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
The Biotech Times Editorial Team  · 
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