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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.
[7] However, in August 2022 Minerva submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the approval of roluperidone for the treatment of schizophrenia. [8] The NDA submission in 2022 followed successful completion of a phase III clinical trial which was published in early 2022.
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 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 ...
Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when ...
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 ...