Biologics
Regulatory Science

Sernova wins FDA Orphan Drug tag for autologous islet transplant

The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

uniQure to file AMT-130 BLA for Huntington's disease in Q3 2026

The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The Biotech Times Editorial Team  · 
Biologics

Utebzi approved as first oral carbapenem for cUTIs in the US

The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The Biotech Times Editorial Team  · 
Biologics

Zelluna ASA raises NOK 58m ahead of first TCR-NK clinical data

The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Biotech Times Editorial Team  · 
Diagnostics

BioAge Labs doses first participant in Phase 2 NLRP3 trial QUELL-CV

BioAge's BGE-102 enters a 160-person dose-ranging trial targeting cardiovascular inflammation, with topline hsCRP data expected in the second half of 2026.
BioAge's BGE-102 enters a 160-person dose-ranging trial targeting cardiovascular inflammation, with topline hsCRP data expected in the second half of 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

Inventiva secures €130m debt facility to fund lanifibranor Phase 3

Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
The Biotech Times Editorial Team  · 
Diagnostics

ConSynance doses first patient in Phase 2a PWS trial of CSTI-500

ConSynance Therapeutics has begun a proof-of-concept trial of its oral triple monoamine reuptake inhibitor in up to 12 Prader-Willi syndrome patients.
ConSynance Therapeutics has begun a proof-of-concept trial of its oral triple monoamine reuptake inhibitor in up to 12 Prader-Willi syndrome patients.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

iMDx GraftAssure matches NGS rival in kidney transplant study

GraftAssure showed 99.2% agreement with a leading NGS-based assay in kidney transplant rejection monitoring, with superior analytical sensitivity at low dd-cfDNA levels.
GraftAssure showed 99.2% agreement with a leading NGS-based assay in kidney transplant rejection monitoring, with superior analytical sensitivity at low dd-cfDNA levels.
The Biotech Times Editorial Team  · 
Biotech

HCW Biologics reports Phase 1 signal for IL-2 fusion drug in alopecia

All three patients in the second dose cohort of HCW9302 showed at least a 25% improvement in SALT scores after a single subcutaneous dose.
All three patients in the second dose cohort of HCW9302 showed at least a 25% improvement in SALT scores after a single subcutaneous dose.
The Biotech Times Editorial Team  · 
Biotech
Regulatory Science

Humacyte prices $50m public offering to fund Symvess rollout

Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
The Biotech Times Editorial Team  · 
Diagnostics

Invivyd completes enrolment in Phase 3 LIBERTY COVID antibody trial

Invivyd has finished enrolling 210 participants in LIBERTY, its Phase 3 head-to-head study of VYD2311 against an mRNA COVID-19 vaccine, with topline
Invivyd has finished enrolling 210 participants in LIBERTY, its Phase 3 head-to-head study of VYD2311 against an mRNA COVID-19 vaccine, with topline
The Biotech Times Editorial Team  · 

nCAP Medical RCT shows NeuroCuple cuts opioid use after knee surgery

A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
The Biotech Times Editorial Team  · 
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