Regulatory Science
Biologics

60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Biotech Times Editorial Team  · 
Biologics

Novo Nordisk ZEUS trial fails to cut cardiovascular events

Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
The Biotech Times Editorial Team  · 
Regulatory Science

Tenax Therapeutics awaits Phase 3 LEVEL readout as R&D spend doubles

Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
The Biotech Times Editorial Team  · 
Digital Health
Biotech

MBRIF welcomes 17 companies into Cohort 12 accelerator programme

The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
The Biotech Times Editorial Team  · 
Regulatory Science

Eton Pharmaceuticals files PAS to extend KHINDIVI to under-fives

Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
The Biotech Times Editorial Team  · 

TScan Therapeutics doses first patient in Phase 3 ALLOHA-2 trial

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
The Biotech Times Editorial Team  · 
Biologics

Celcuity gedatolisib gains NCCN Category 1 status in breast cancer

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
The Biotech Times Editorial Team  · 
Biologics

Madrigal Pharmaceuticals posts $364m Q2 Rezdiffra sales, up 71%

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
The Biotech Times Editorial Team  · 
Biologics

Keros Therapeutics earns $20m milestone as elritercept Phase 3 enrols

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
The Biotech Times Editorial Team  · 
Biologics

Sanofi upgrades 2026 guidance after 17.8% Q2 sales growth

Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
The Biotech Times Editorial Team  · 
Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Biotech Times Editorial Team  · 
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