Covaxin’s launch in U.S. to be delayed after FDA requests additional data
The Hindu
The company anticipates that data from an additional clinical trial will be required to support the submission.
In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the U.S. Food and Drug Administration has “ recommended” Ocugen Inc, the U.S. partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the FDA,it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a “full approval” mechanism by the FDA for drugs and vaccines.
Tamil Nadu government ministers stand firm against Hindi imposition and demand rightful share of funds.
Stampedes at religious events in India have caused hundreds of deaths over the years, highlighting safety concerns.
RSS chief Mohan Bhagwat urges people to understand the organisation's goal of uniting Hindu society, emphasizing close contact over distance.
Madurai Reader’s Mail
Congress accused Himanta Biswa Sarma of indulging in an “atrocious smear campaign” against Gaurav Gogoi.
Historic one-day Assembly session in Kokrajhar symbolizes peace and integration, a major highlight of Chief Minister Sarma's tenure.
The debate on reservation in judicial appointments for diversity and representation in the Supreme Court and High Courts.
Boosting business confidence, India and U.S. aim to double commerce to $500 billion by 2030 through bilateral trade agreement.
Actors Vikrant Massey and Bhumi Pednekar advise students to focus on life skills, not just exams, during PM's Pariksha Pe Charcha.
Two Rajpura youths deported from the U.S. arrested for murder upon landing at Amritsar airport.
Fatal accident on Purvanchal Expressway in Barabanki; tempo-traveller collides with bus, leaving 4 dead and 6 injured.
Vizianagaram district installs CC cameras on State Highways to reduce accidents, identify vehicles, and promote road safety.
Andhra Pradesh CM N. Chandrababu Naidu mourns the death of film producer and actor Krishna Veni, honoring her contributions.