Regulatory
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
Tricida plans to request a Type A meeting with the FDA, which is expected to take place in the fourth quarter of this year. This meeting will decide the future of veverimer.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
The U.S. FDA reversed itself Sunday following pressure from the White House and announced an Emergency Use Authorization for convalescent plasma as a treatment for patients who have contracted COVID-19.
August has been a busy month for the U.S. Food and Drug Administration. The final two weeks are marked by a number of PDUFA dates, although a few of those drugs have already been approved.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.
The U.S. FDA placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for COVID-19 over what was described as a lack of robust data supporting its use.
The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.
The company indicates the agency requested data from the MANTA and MANTA-Ray trials before completing its review of filgotinib. Here’s more about it.
PRESS RELEASES