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Latest From Xbrane Biopharma AB

EMA OKs First Drug To Prevent RSV Infection In Babies

A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.

Europe Approvals

Stada And Xbrane Win EU Endorsement For Ranibizumab

Stada and Xbrane have celebrated an endorsement from the EMA’s CHMP for their Ximluci ranibizumab biosimilar rival to Lucentis. The development follows a setback for a parallel filing in the US.

Biosimilars Approvals

AstraZeneca/Sanofi’s RSV Shot Among 13 Hopefuls Awaiting EU Verdict

Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.

Europe Approvals

Xbrane Reveals Ranibizumab Refiling Plans For US

Xbrane has set out its plans to resubmit its application for a biosimilar rival to Lucentis in the US, after receiving details from the FDA on additional information needed for the agency to accept the BLA for review.

Biosimilars Strategy
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