Search results
Results from the WOW.Com Content Network
Avapritinib, sold under the brand name Ayvakit among others, is a medication used for the treatment of advanced systemic mastocytosis and indolent systemic mastocytosis. It is also used for the treatment of tumors due to one specific rare mutation: it is specifically intended for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbor a platelet-derived growth ...
The FDA approved avacopan based on evidence from a clinical trial of 330 participants with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. [12] In the clinical trial, participants were randomly assigned to receive avacopan or placebo for 52 weeks. [ 12 ]
The FDA approved mitapivat based on evidence from two clinical trials of 107 participants with pyruvate kinase deficiency. [3] Trial 1 (NCT03548220) of 80 adults with pyruvate kinase deficiency who did not receive regular blood transfusions and trial 2 (NCT03559699) of 27 adults with pyruvate kinase deficiency who received regular blood transfusions. [3]
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 drug, BMF-219, was being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study in type 1 diabetes. The drug developer said the FDA cited deficiencies based on the ...
In April 2021, the US Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli, GSK). [6] Efficacy was evaluated based on cohort (A1) in Garnet Trial (NCT02715284), a multicenter, multicohort, open-label trial in participants with advanced solid tumors. [ 6 ]
The Boston-based company denied allegations of breach of clinical trial guidelines, and said the U.S. Food and Drug Administration's inspection did not result in any Form 483 observations at its ...
The trial was conducted at 53 sites in the United States, South Korea, Taiwan, Japan, Great Britain, France, Spain, Canada, China, and Australia. [15] The FDA collaborated on the review of amivantamab with the Brazilian Health Regulatory Agency (ANVISA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). [6]