Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.

The FDA has issued another complete response letter (CRL) to Regeneron, rejecting its bid for approval of its prefilled syringe version of high-dose (HD) Eylea—again for unresolved issues at the ...

Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing ...

Kemwell Biopharma’s Bengaluru facility earns U.S. FDA approval for commercial biologics manufacturing, expanding India’s global CDMO footprint.

Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales(recorded by Sanofi) increased 27% ...

Kemwell’s FDA-approved site features single-use and stainless-steel bioreactors, with over 5000L+ of installed upstream capacity, commercial fill-finish lines for liquid and lyophilized vials, and pre ...

With the safePICO self-fill blood gas syringe, you can improve your mixing and get results you can trust. Mixing ball helps you obtain a homogeneous sample SafeTIPCAP minimizes the risk of blood ...

Custom formulations of popular weight loss medications have surged in popularity due to shortages and high costs. Here’s what ...

For years, Texas patients seeking relief through the Texas medical cannabis program had only a few ways to take their ...

The solution accelerates syringe selection through its comprehensive performance and regulatory data packages.

Combining optimized safety and security, Schreiner MediPharm's Cap-Lock plus RFID ensures product integrity while increasing ...