Tag: EUA
Bharat Biotech’s Covaxin gets emergency approval for 6-12 age group
Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study in children 2-18 years of age
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
Biological E’s COVID-19 vaccine gets EUA nod for 12-18 years age...
The Drugs Controller General of India (DCGI) has already approved CORBEVAX for restricted use in emergency situation among adults on December 28, 2021
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...................
Biophore applies for DCGI emergency use approval of Aviptadil for COVID-19
Aviptadil has shown significant results in clinical trials against COVID-19. Biophore has developed both the API and the formulation in-house...........................
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...........
Jubilant launches JUBI-R, its generic version of COVID-19 drug remdesivir in...
Jubilant Generics, a subsidiary of Jubilant Life Sciences has launched remdesivir for injection under the brand name ‘JUBI-R’ in the Indian market at a price of INR 4,700 per vial of 100 mg (lyophilized injection)........................