Ocugen had to change the Pennsylvania-based eye disease company’s application for the Covid-19 vaccine Covaxin from an Emergency Use Authorization to a full Biologics License Application (BLA) approval.
The U.S. health regulator authorized a lower dose of Regeneron Pharmaceuticals’ Covid-19 antibody cocktail that can be given by injection, a move that could ease logistical challenges stemming from administering a higher dose intravenously.
The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in people aged 12 years and older.
Roche’s cobas SARS-CoV-2 Test received U.S. authorization for testing individuals without symptoms or reasons to suspect a Covid-19 infection, the Swiss drugmaker said on May 18.
U.S. regulators on May 10 authorized Pfizer and BioNTech’s Covid-19 vaccine for use in children as young as 12 years and said they could begin receiving shots as soon as May 11, widening the country’s inoculation program as vaccination rates have slowed significantly.
Inovio Pharmaceuticals said on April 23 the U.S. government had stopped funding for a late-stage study testing the company’s Covid-19 vaccine candidate, due to the increasing availability of authorized shots in the country.
Eli Lilly requested cancellation of the U.S. authorization granted to the company’s Covid-19 antibody bamlanivimab, which will now be used in combination with another to achieve greater efficacy against emerging virus variants.
Pfizer Inc. and the company’s German partner BioNTech SE on April 9 asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15 years old.
Eli Lilly and Co. and Incyte Corp. said their rheumatoid arthritis drug baricitinib did not meet the main goal of preventing progression to mechanical ventilation in hospitalized Covid-19 patients under a late-stage study.
Abbott received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of the company’s BinaxNOW COVID-19 Ag Self Test for detection of COVID-19 infection.