Pharmaceutical Technology27m
FDA accepts BMS’ Opdivo-Yervoy combo sBLA for colorectal cancer
The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence application (sBLA) for Opdivo and Yervoy ...
Targeted Oncology17h
FDA Accepts sBLA for Nivolumab/Ipilimumab Combo in dMMR/MSI-H CRC
Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...
FDA accepts Bristol Myers’ sBLA for Opdivo plus Yervoy
Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...
SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag
The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for bullous pemphigoid by June 20, 2025.
Contract Pharma18h
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo Plus Yervoy
The application was based on results from the three-arm Phase 3 CheckMate -8HW study.
2BMY : Bristol Myers Colorectal Cancer Treatment Goes Under Priority FDA Review
Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...
The Zacks Analyst Blog Highlights Merck, Sanofi, Regeneron and Ionis
Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the ...
dermatologyadvisor17h
Dupilumab Gets Priority Review for Bullous Pemphigoid
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.
GlobalData on MSN6d
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...
The Pharma Letter6d
FDA accepts Dupixent sBLA for priority review in bullous pemphigoid
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application ...
Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for ...
Contract Pharma6d
sBLA for Dupixent Accepted by FDA for Priority Review
Priority review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious ...