FDA
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
Boehringer announced that the FDA approved Spevigo for generalized pustular psoriasis flares in adults, the first drug approved for this indication.
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.
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