Approvals
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 2, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
PRESS RELEASES