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The approval is based on a late-stage study in which PiaSky showed a 79.3% control in the destruction of red blood cells versus 79% for the standard-of-care eculizumab from week 5 to week 25.
Here is the list in order of FDA approval date. Read On The Fox News App. 1. Dupixent – Additional use: Eosinophilic esophagitis (an allergic condition that causes inflammation of the esophagus ...
(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called ...
The 2024–25 network television schedule for the five major English-language commercial broadcast networks in the United States covers the prime time hours from September 2024 to August 2025. The schedule is followed by a list per network of returning series, new series, and series canceled after the 2023–24 television season .
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.
The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs) and 505(b)(2) applications. The voucher, which ...