FDA begins follow-up inspection at Xspray Pharma manufacturer NerPharMa over compliance issues
Bitget2026/11/05 16:59- The FDA has begun an unannounced follow-up inspection at Xspray Pharma’s contract manufacturer NerPharMa in Italy over previously identified manufacturing compliance issues.
- Approval of Dasynoc and Nilopki remains conditional on satisfactory current good manufacturing practice status at NerPharMa.
- Plans to resubmit both drug applications in the fourth quarter of 2026 remain unchanged; resubmissions can proceed independently of NerPharMa’s compliance status.
- The FDA generally aims to notify facilities of final inspection classifications within 90 days of completing inspections.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
You may also like
Cybertruck orders far exceed pre-production capacity, Tesla (TSLA.US) to refund deposits to a large number of customers
Elon Musk stated that Tesla will refund the Cybertruck deposits to a significant number of customers.
Barrick Gold (B.US) Q3 Results Mixed: Benefiting from Gold Price Dividend While Facing Cost Pressures
Barrick Mining (B.US) will release its financial results for the third quarter of 2026 before the U.S. stock market opens on November 9.
Europe Becomes a Safe Haven Amid AI Turbulence! Citi Turns Bullish on European Stocks, Downgrades US Stocks: Low AI Exposure Seen as Key Advantage
Citigroup strategists have downgraded the rating of U.S. stocks and upgraded the rating of European stocks, following the recent market turbulence caused by upheaval in the artificial intelligence industry.
Crypto prices
More
