FDA
On Wednesday, the FDA authorized new Omicron-specific booster shots for Pfizer-BioNTech and Moderna’s COVID-19 vaccines despite a lack of human data.
Sanofi announced FDA approval of Xenpozyme for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency, often referred to as Niemann-Pick disease.
The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped.
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
The FDA has had a busy week, accepting drug applications, approving clinical trials and granting various special designations for Gamida Cell, Cellectis, Scynexis & more.
FDA has approved GSK’s Benlysta (belimumab), making it the first biologic treatment for children ages 5 to 17 with lupus nephritis.
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
PRESS RELEASES