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The United States and Canada.
Regulatory Science

Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104

Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
The Biotech Times Editorial Team  · 
Biologics

Memo Therapeutics presents full Phase II potravitug data at ATC 2026

Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
The Biotech Times Editorial Team  · 
Regulatory Science

Teva files NDA for ecopipam in paediatric Tourette syndrome

Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
The Biotech Times Editorial Team  · 
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
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
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
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

Odyssey Therapeutics IPO raises $315m as OD-001 hits UC proof-of-concept

The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Biotech Times Editorial Team  · 
Biologics

Lexeo Therapeutics publishes LX2006 Phase I/II data in JAMA Cardiology

Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
The Biotech Times Editorial Team  · 
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The Biotech Times Editorial Team  · 
Biologics

Connect Biopharma fills Phase 2 asthma study of rademikibart

The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The Biotech Times Editorial Team  · 
Biologics

Biogen to acquire RayThera for up to $1bn to bolster immunology pipeline

Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
The Biotech Times Editorial Team  · 
Diagnostics

Avalyn completes Phase 2b MIST enrollment for inhaled pirfenidone

Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
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  · 
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  · 
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  · 
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  · 
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  · 
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  · 
Regulatory Science

NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
The Biotech Times Editorial Team  · 
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