Tag: Ocugen
First ever human patient dosed with Gene Therapy in Ocugen’s Phase...
This first patient dosing marks the beginning of the dose-escalating, observer-blind, Phase 1/2 safety and efficacy study
USFDA declines EUA nod to Covaxin
Despite receiving emergency use listing from the World Health Organization, Covaxin has not been cleared for any age group in the United States
Bharat Biotech’s partner seeks Covaxin nod in US for children between...
Covaxin, developed in India by Bharat Biotech, gained emergency approval from the World Health Organization (WHO) and has already been cleared for use in 17 countries......................
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...................
Ocugen expands COVAXIN commercialization rights to include Canada
Ocugen to have exclusive co-development, manufacturing, and commercialization rights to COVAXIN in Canada, in addition to its existing US rights.....................
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...........