The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence ...

The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application ...

The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...

The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...

Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...

The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for bullous pemphigoid by June 20, 2025.

Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...

Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major ...

Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the ...

Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...

The application was based on results from the three-arm Phase 3 CheckMate -8HW study.

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application ...