Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.
Moderna announced on June 1, 2021 that it has initiated a rolling submission process with FDA for a biologics license application (BLA) for its messenger RNA (mRNA) COVID-19 vaccine for individuals 18 years of age and older.
The company will continue to submit data to FDA on a rolling basis to support the BLA over the next few weeks with a request for priority review, Moderna said in a company press release. When the submission is completed, FDA will notify the company when the vaccine is formally accepted for review.
Currently, the vaccine is available in the United States under an emergency use authorization granted by FDA on December 18, 2020.
“We are pleased to announce this important step in the US regulatory process for a BLA of our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in the press release. “We look forward to working with [FDA] and will continue to submit data from our Phase III study and complete the rolling submission.”
Source: Moderna
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.