Approvals
Applied Therapeutics said it is holding off on a New Drug Application after discussions with the FDA, which appears to require additional clinical data.
Just as 2021 was wrapping up, the U.S. FDA had some end-of-year activity. Here’s a look.
Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
The decision to allow the release of Adbry follows positive results from the Phase III ECZTRA trials, which covered almost 2,000 patients living with moderate to severe atopic dermatitis.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
The FDA has approved Novartis’ new drug for lowering bad cholesterol. Leqvio is the first and only siRNA treatment that can reduce low-density lipoprotein cholesterol.
The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
PRESS RELEASES