Gallium 68 PSMA-11 Approved for Prostate Cancer Detection
The approval was based on efficacy and safety data from 2 prospective clinical trials.
The approval was based on efficacy and safety data from 2 prospective clinical trials.
The latest on the vaccine development from Moderna, and BioNTech and Pfizer as they release more trial data; An at-home diagnostic test is approved; Keytruda gains expanded approval; And all the rest of the drug news from this past week.
This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.
Benefit substantial for adults aged 50 to 75 years; benefit moderate for adults aged 45 to 49 years.
This week we cover new Moderna vaccine results; Boxed Warning for benzodiazepines; Point-of-care COVID-19 antibody test; Diphenhydramine overdoses linked to TikTok ‘challenge’; And FDA grants Nucala new approval. Also we look at this week’s developments in drugs in the pipeline.
Rapid test at airport provides results in about 20 minutes and will cost $250
The reissued EUA allows for fingerstick blood samples to be tested in point-of-care settings.
Detectnet (copper Cu 64 dotatate) is indicated for use with PET for localization of somatostatin receptor positive neuroendocrine tumors.
The ACIP release guidelines for the 2020-2021 vaccination recommendations; In COVID, there’s developments in convalescent plasma authorization, a 15 minute test, and ethnobotanist’s give a stark warning concerning a plant that some are touting as a cure. In other news an intrauterine device gains expanded approval and there’s a label update for hydrochlorothiazide.
Results are provided within 15 minutes and can be read directly from the testing card.