Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia
The Notes shall not be offered or sold in India
Stable profits, low leverage to keep credit profiles comfortable
The company will now seek final approval from NCLT, Mumbai Bench, and upon its receipt, OneSource will proceed to seek listing approvals from the BSE and NSE
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
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