The FDA's earlier decision, in April, to put on hold the trials was based on the US firm's decision to voluntarily implement a temporary pa...

"The company was informed by the USFDA that the agency placed its phase 2/3 immuno-bridging and broadening study for Covaxin (BBV152), OCU-...

Last month, Bharat Biotech had announced that Covaxin would be assessed in the United States as a COVID-19 vaccine candidate.

"We are pleased to be able to move our clinical program for Covaxin forward, which we hope will bring us closer to offering an alternative ...

Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries as on January 31 according to the WHO. Covaxin was granted EUL...

The US-based firm has applied for the authorisation based on the basis of the results of phase 2 and 3 clinical trials conducted on 526 chi...

The US Centers for Disease Control (CDC) on Wednesday acknowledged the World Health Organisation's (WHO) granting emergency use listing (EU...

The US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experience...

"No vaccine manufactured or developed in India has ever received Emergency Use Authorisation or full licensure form the USFDA,” it said in ...

Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA...

This follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to ...

Inclusion in the EUL is also important for easy international travel of Indian citizens who have been administered Covaxin.

Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clin...

The Pennsylvania-based biopharmaceutical firm is partnering with India's Bharat Biotech, a developer of the vaccine, to commercialize the s...

Considered one of the most influential Indian-American community leaders in the US, Dr Bharat Barai alleged that certain people and media a...

On orders of FDA Commissioner Harshadeep Kamble, the FDA team kept a watch and carried out a test purchase through a fake customer.

Following rejection of six consignments of basmati rice by US on the ground that they contain ‘filth’, India has issued an advisory to expo...