Genomics

Novartis del-brax Phase I/II FSHD study meets primary biomarker endpoint

Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
The Biotech Times Editorial Team  · 
Biotech

Immuneering doses first patient in Phase 3 pancreatic cancer trial

The MAPKeeper 301 trial will test atebimetinib plus modified chemotherapy in first-line metastatic PDAC, with topline overall survival data expected in mid-2028.
The MAPKeeper 301 trial will test atebimetinib plus modified chemotherapy in first-line metastatic PDAC, with topline overall survival data expected in mid-2028.
The Biotech Times Editorial Team  · 
Diagnostics

Caribou Biosciences CB-011 shows 83% CR rate in r/r myeloma at EHA

Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
The Biotech Times Editorial Team  · 
Bioinformatics

Nurix BTK degrader bexobrutideg shows 92.9% ORR in second-line CLL

Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
The Biotech Times Editorial Team  · 
Bioinformatics

Syndax SAVE trial data published in JCO showing 88% ORR

Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
The Biotech Times Editorial Team  · 
Diagnostics

Roche's Tecentriq wins FDA Priority Review in stage III colon cancer

The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The Biotech Times Editorial Team  · 
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The Biotech Times Editorial Team  · 
Diagnostics

Kura and Kyowa Kirin report 94% 12-month survival in AML combo trial

KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

OraSure wins FDA clearance for at-home STI urine collection kit

OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Climb Bio posts Phase 1b ITP data for budoprutug at EHA 2026

Early data from 15 heavily pretreated patients show robust B-cell depletion and durable platelet responses, with no serious adverse events reported.
Early data from 15 heavily pretreated patients show robust B-cell depletion and durable platelet responses, with no serious adverse events reported.
The Biotech Times Editorial Team  · 
Regulatory Science

Ascendis Pharma reports five-year Phase 2 data for TransCon PTH

Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
The Biotech Times Editorial Team  · 
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