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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 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 Food and Drug Administration (FDA) has revoked the use of Red Dye No. 3 (also known as erythrosine, Red Dye 3, FD&C Red No. 3 and Red No. 3) in food and ingested drugs as of January 15 ...
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.
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 ...
Minerva believed that the findings of this second trial supported the claim that the drug was an effective agent for the treatment of negative symptoms in schizophrenia. However, in October 2022, FDA sent Minerva a refusal to file letter pertaining to the New Drug Application for roluperidone for treating negative symptoms in schizophrenia ...
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.
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 ...