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BioWorld - Friday, June 6, 2025
Home » Topics » Regulatory

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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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FDA approves Apadaz for short-term management of acute pain

Feb. 26, 2018

EC first to approve Crysvita for treatment of X-linked hypophosphatemia

Feb. 26, 2018

Xofluza approved in Japan for treatment of influenza types A and B

Feb. 23, 2018

FDA approves Imfinzi for unresectable stage III NSCLC

Feb. 19, 2018

Gilead Sciences' Harvoni approved for new indication in Japan

Feb. 19, 2018

FDA approves Erleada for non-metastatic castration-resistant prostate cancer

Feb. 15, 2018

FDA approves Symdeko to treat underlying cause of cystic fibrosis

Feb. 13, 2018
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