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Home » Topics » Regulatory

Regulatory
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Japanese approval for Orkedia

March 27, 2018

Lenvima approved in Japan for unresectable HCC

March 26, 2018

European Commission approves Alofisel

March 26, 2018

FDA expands Tasigna indications for pediatric patients with CML

March 23, 2018

Lokelma receives E.U. approval for hyperkalemia

March 23, 2018

FDA approves Ilumya for moderate to severe plaque psoriasis

March 21, 2018

FDA approves CSL Behring's Hizentra in new indication

March 16, 2018

Solifenacin oral suspension for pediatric patients approved in Europe

March 12, 2018

FDA approves Trogarzo for multidrug-resistant HIV-1

March 7, 2018

23andme wins FDA nod for BRCA gene report

March 7, 2018
By Katie Pfaff
The FDA has granted de novo approval to 23andme Inc. for its report on BRCA1 and BRCA2 risk for developing breast, prostate or ovarian cancer. The direct-to-consumer (DTC) saliva test can provide insight on three genetic mutations linked to the cancers, most commonly found in patients of Eastern European, or Ashkenazi Jewish heritage, which account for a relatively small portion of patients. There are more than 1,000 mutations of the BRCA gene, and the test is not intended to diagnose or rule out the presence of mutation, or increased risk of the particular cancers due to other factors.
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