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

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  · 

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

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
The Biotech Times Editorial Team  · 
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The Biotech Times Editorial Team  · 
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pfizer-BioNTech win EC nod for XFG-adapted COVID-19 vaccine

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The Biotech Times Editorial Team  · 
Biologics

Ipsen raises FY 2026 guidance after 23.5% CER sales growth in H1

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
The Biotech Times Editorial Team  · 
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
The Biotech Times Editorial Team  · 
Biologics

MiMedx to acquire Sanara MedTech in $350m regenerative medicine deal

MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
The Biotech Times Editorial Team  · 
Biologics
Digital Health
Diagnostics

Clue data study links follicular-phase vaccination to more side effects

Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
The Biotech Times Editorial Team  · 
Regulatory Science

PharmAla grants Jupiter Neurosciences exclusive U.S. rights to ALA-002

PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
The Biotech Times Editorial Team  · 
Subscribe to