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Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a ...
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases.
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 FDA meets next week to publicly review evidence from a small, mid-stage study of Amylyx Pharmaceuticals’ drug for ALS, or amyotrophic lateral sclerosis. Pressured by patients, FDA reviews ...
Ball-and-stick model of Ivermectin. Ivermectin is an antiparasitic drug that is well established for use in animals and people. [1] The World Health Organization (WHO), [2] the European Medicines Agency (EMA), [3] the United States Food and Drug Administration (FDA), [4] and the Infectious Diseases Society of America (IDSA) [5] all advise against using ivermectin in an attempt to treat or ...
Mirikizumab, a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis, also sends Crohn's disease into clinical remission, new findings suggest.
[156] [157] It was approved in the United Kingdom later that month, [158] and in the European Union and Canada in January 2022. [159] [160] [161] In May 2023, it was approved in the U.S. to treat mild to moderate COVID‑19 in adults who are at high risk for progression to severe COVID‑19, including hospitalization or death.
Entolimod (CBLB502) is being developed by Cleveland Biolabs, Inc. for dual indications under the U.S. Food & Drug Administration’s (FDA) animal efficacy rule as a pivotal-stage radiation countermeasure, and under the FDA’s traditional drug approval pathway as a cancer treatment.