Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Alpha Tau completes 48-patient IMPACT pancreatic cancer enrolment

Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

Discovery Health data shows women lead Personal Health Pathways uptake

Discovery Health reports female members complete 1.5 times more preventive health actions than male members on its AI-powered Personal Health Pathways platform.
Discovery Health reports female members complete 1.5 times more preventive health actions than male members on its AI-powered Personal Health Pathways platform.
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

XYRA doses first European patient in budiodarone AF trial

XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
The Biotech Times Editorial Team  · 
Biologics

Arch Biopartners wins IRB approval to open U.S. sites in CS-AKI trial

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Ascendis and BioMarin settle YUVIWEL dispute with royalty deal

Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
The Biotech Times Editorial Team  · 
Medical Devices

Beyond Air wins FDA Breakthrough Device tag for LungFit GO in NTM-PD

Beyond Air's portable inhaled nitric oxide device gains FDA Breakthrough Device Designation for a rare, hard-to-treat chronic lung infection.
Beyond Air's portable inhaled nitric oxide device gains FDA Breakthrough Device Designation for a rare, hard-to-treat chronic lung infection.
The Biotech Times Editorial Team  · 
Regulatory Science

Cadrenal Therapeutics gains FDA alignment on CAD-1005 Phase 3 design

The FDA agreed on the primary endpoint and placebo-control design for Cadrenal's Phase 3 trial of its 12-LOX inhibitor in heparin-induced
The FDA agreed on the primary endpoint and placebo-control design for Cadrenal's Phase 3 trial of its 12-LOX inhibitor in heparin-induced
The Biotech Times Editorial Team  · 
Biologics

Lecanemab gets positive CDA-AMC reimbursement nod in Canada

Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
The Biotech Times Editorial Team  · 
Regulatory Science

Palvella completes NDA submission for QTORIN rapamycin gel in rare LM

Palvella Therapeutics has filed its full NDA with the FDA for QTORIN rapamycin gel, targeting a rare condition with no approved treatment options.
Palvella Therapeutics has filed its full NDA with the FDA for QTORIN rapamycin gel, targeting a rare condition with no approved treatment options.
The Biotech Times Editorial Team  · 
Biologics

Disc Medicine to present first DISC-3405 clinical data at SOHO 2026

Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.
Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.
The Biotech Times Editorial Team  · 
Subscribe to