The U.S. Food and Drug Administration (USFDA) has approved a Biologics License Application (BLA) for a proposed biosimilar for Orencia (abatacept). The company’s 351(k) Biologics License Application (BLA) IV for infusion formulation for DRL-AB, for the proposed interchangeable biosimilar, was submitted in December 2025. “We are proud to be the first to submit a BLA […]
Biocon shares rose 2% to RS 364 on Friday 5 September, after the announcement of the company that the US Food and Drug Administration (FDA) has completed a routine good manufacturing practice (CGMP) -Specture (CGMP) on Biocon Biocon -Campance Facility in the Biocon -Campance Facility Observations. The Inspectorate, carried out between August 26 and September […]