Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Shots: Xbrane Biopharma has resubmitted the BLA for its biosimilar of Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024 The CRL stated requirement of additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…

ByadminJanuary 1, 2025

EVENTS

Exclusive Coverage: Key Takeaways from the DIA India Medical Devices Conference 2020

The DIA India Medical Devices Conference 2020 is the first effort of DIA India to bring together leaders from the medical devices industry, regulatory and academia from India in New Delhi to discuss the current landscape and regulatory updates of the medical devices industry. New upcoming medical devices regulations, changing landscapes and the evolution of…

ByadminMarch 2, 2020

admin

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Exclusive Coverage: Key Takeaways from the DIA India Medical Devices Conference 2020

Contact US

OUR INFORMATION

FOLLOW US