GlobalData on MSN10h
FDA accepts BMS’ Opdivo-Yervoy combo sBLA for colorectal cancer
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence ...
The Pharma Letter3h
FDA grants priority review to Merck’s sBLA for Keytruda
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application ...
Targeted Oncology1d
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 ...
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.
Pharm Exec2h
FDA Grants Priority Review to Merck’s Keytruda for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major ...
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 ...
Merck’s application for keytruda in HNSCC granted priority review by FDA
Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...
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 ...
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 ...
Contract Pharma1d
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.
The Pharma Letter7d
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 ...
Contract Pharma7d
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 ...