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Right-to-try laws are United States state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA). Prior to the passage of right to try laws ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
HRDetect was implemented to detect tumors with BRCA1/BRCA2 deficiency using the data from whole-genome sequencing. This model quantitatively aggregates six HRD-associated signatures into a single score called HRDetect to accurately classify breast cancers by their BRCA1 and BRCA2 status.
The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer.
The US Food and Drug Administration approved a novel tool Tuesday that uses genetic testing to help assess whether certain people are at risk of developing opioid use disorder.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
The test, AvertD, is developed by privately held SOLVD Health. The FDA granted the approval to AutoGenomics, a unit that SOLVD acquired in 2019. AvertD is intended to be used before the first use ...
It was approved on 27 March 2017 in the US, [5] and approved in European Union on 16 November 2017. [ 15 ] In a study with 553 patients, progression-free survival (PFS) for patients with a deleterious or suspected deleterious BRCA mutation in the germline was 21.0 months under niraparib therapy, as compared to 5.5 months under placebo .