Urtė Fultinavičiūtė

Celltrion gave updates on several business aspects and reassured its shareholders that the delayed insurance listing for Zymfentra will not affect its set annual sales goal.

After a “remarkable performance” in Q2, Samsung Bioepis enjoyed a calm, but still profitable, third quarter.

Respondents to the FDA's questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?

Also, Finalized FDA Guidances And Regulatory Updates From Canada, Indonesia, And Malaysia Generics Bulletin reviews the latest regulatory developments across the world.

After under-delivering on already muted expectations, Biocon's optimistic future was overshadowed by pending FDA inspection outcomes on two of its facilities.

Despite calls to amend the Urban Wastewater Treatment Directive to protect essential and critical medicines, the EU Council gave its final approval.

As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.

Amneal knows what it wants and is determined to get it. With more and more complex products being added to its portfolio, the firm marks another “terrific” quarterly performance.

With most regions reporting double-digit growth in the second quarter, analysts' opinions differ about Lupin's future.

Medicines for Ireland had its demands for the off-patent sector heard by some political parties, which are pledging to improve access to generic and biosimilar drugs ahead of the election.