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regulatory approval

UgenTec and R-Biopharm's collaboration will cover the software's development, regulatory approval, and launch.

The belief among genomics experts that one day drugs would be given based on genomic abnormalities that cut across tumor types became reality this week.

The New York State Department of Health had previously provided conditional approval of the microRNA classifier for diagnosing indeterminate thyroid cancer cases.

Researchers saw a small, but significant uptick in self-reported healthy eating and exercise frequency after 23andMe or Pathway Genomics DTC testing.

The re-emergence of direct-to-consumer genetic health risk tests has healthcare providers worried once again about their impact and utility.

Following the premarket authorization of 23andMe's tests, the agency may allow other firms to sell similar tests DTC without having to submit them for review.

Bit Quicker, Actually

An analysis in the New England Journal of Medicine finds that the US Food and Drug Administration reviews new drugs faster than the European Medicines Agency.

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).

The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.

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Researchers tie a variant in ADAMTS3 to breathing difficulties in dissimilar dog breeds, according to Discover's D-brief blog.

Parents of children with rare genetic disease have to contend with shifts in the interpretation of genetic variants, the Wall Street Journal reports.

The Japan Times reports that researchers sequenced the genome of a woman who lived during the Jomon period.

In Science this week: single-nucleus RNA sequencing of brain tissue from individuals with autism, and more.