Approvals
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Despite the constant need for social distancing, mask-wearing, and the isolation and economic uncertainty that resulted from the outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year.
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
The U.S. FDA approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Late Friday, the FDA gave the green light to Regeneron’s REGN-COV2, a combination of casirivimab and imdevimab.
The EUA for the combination of Olumiant and Remdesivir marks the first combination for COVID-19 greenlit in the U.S.
The U.S. Food and Drug Administration has four distinct approaches to speeding the drug approval process. Several of today’s announcements had one or more of these designations.
PRESS RELEASES