OCUGEN

More in OCUGEN

• FDA declines pediatric EUA for Ocugen's COVID vaccine Covaxin

  Ocugen said it intends to continue working with the U.S. Food and Drug Administration to evaluate the process for getting an EUA for pediatric use of Covaxin.

  

• Bharat Biotech's US partner Ocugen files EUA request with FDA for paediatric use of Covaxin

  Some research suggests that people are seeking more choices when selecting a vaccine, especially for their children. Having a new type of vaccine available will enable people to discuss with their child's physician the best approach for them to lower their child's risk of contracting COVID-19,

  

• Bharat Biotech's US partner Ocugen files request with FDA for Covaxin trials

  The US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the USA.

  

• Covaxin under ‘active review’ of Health Canada

  He said the regulatory submission filed under Canada’s interim order was transitioned into a new drug submission for Covid-19 “in such a short order, especially when urgency is increasing in Canada”.

  

• Pre-submission meet held, Covaxin's 'rolling data' to start in July: WHO

  Stating that its COVID-19 vaccine Covaxin adheres to international standards, Bharat Biotech's joint managing director Suchitra Ella on Tuesday said external timelines are in the company's hands.

  

• FDA denies emergency use nod for Covaxin in US

  The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said.

  

• FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech

  Bharat Biotech said the biological license application process is the standard process for vaccines.

  

• Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUA

  Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more information and data for the full approval.

  

• Ocugen pays USD 15 mn upfront to Bharat Biotech for Covaxin rights in Canada

  Bharat Biotech on June 3 said it has agreed to expand the agreement with Ocugen Inc to commercialise the jab in Canada also.

  

• Bharat Biotech's US partner Ocugen submits "Master File" to FDA on Covaxin

  The company is currently evaluating the clinical and regulatory path for Covaxin in the United States including obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).