Search results
Results From The WOW.Com Content Network
In 2007, Hemispherx filed a new drug application with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS, [6] but this was rejected in December 2009, because the FDA concluded that the two randomized controlled trials "did not provide credible evidence of efficacy" [7] [8] and "because of ...
The U.S. Food and Drug Administration's approval makes the drug, chemically known as semaglutide, to become the first GLP-1 treatment option for people with type 2 diabetes and CKD.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
On Friday, Moderna Inc. (NASDAQ:MRNA) announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1. The submission is ...
If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval. [1] [2] A study published in 2023, following a similar study focused on oncology in 2022, suggested that the Accelerated Approval Program was having the intended impact of shortening the timeline to either traditional approval or ...
The FDA had given accelerated approval for Elahere in Nov. 2022, based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Swiss-based ...