Tag: BLA
Bharat Biotech clarifies on the US-FDA’s EUA denial for COVAXIN
As per Bharat Biotech, its US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval instead of EUA...................
Bharat Biotech signs deal with Ocugen to commercialize Covaxin in US...
Ocugen to receive an initial supply of COVAXIN™ doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US. The vaccine is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients...........
USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review
The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...