Bristol Myers Squibb Announces Acceptance Of FDA And EU Regulatory Filings For Neoadjuvant Opdivo (Nivolumab) And Chemotherapy Followed By Surgery And Adjuvant Opdivo In Resectable Non-small Cell Lung Cancer, The FDA PDUFA Goal Date Of October 8
Portfolio Pulse from Benzinga Newsdesk
Bristol Myers Squibb announced the acceptance of FDA and EU regulatory filings for Opdivo (Nivolumab) and chemotherapy for resectable non-small cell lung cancer, with an FDA PDUFA goal date of October 8. The EMA validated the application in late January, starting its review process.
February 07, 2024 | 12:03 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Bristol Myers Squibb's regulatory filings for Opdivo in resectable non-small cell lung cancer have been accepted by the FDA and EU, with an FDA PDUFA goal date of October 8.
The acceptance of regulatory filings by both the FDA and EU for Bristol Myers Squibb's Opdivo represents a significant step forward in the treatment of non-small cell lung cancer. The setting of an FDA PDUFA goal date indicates a timeline for potential approval, which could enhance the company's product portfolio and potentially boost its stock price in the short term. The positive regulatory milestones are likely to be viewed favorably by investors.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100