FDA Approval Articles

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03/23/2018 06:55 PM


FDA launches app that lets you search for drug information
As the Food and Drug Administration continues to dip its toes in the world of digital health, it announced on Thursday the launch of its Drugs@FDA Express mobile app, which lets people search for information about FDA-approved brand and generic drugs ...

03/23/2018 03:47 PM

Statement from FDA Commissioner Scott Gottlieb, MD, on a key step in advancing FDA's oversight of drug ...
Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs. However, because compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety ...

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03/23/2018 02:37 PM


How 23andMe Quelled FDA Concerns About DTC Breast Cancer Gene Test
When the FDA approved 23andMe's direct-to-consumer test for some BRCA1/BRCA2 gene mutations on March 6, it did so with caveats. The test, which will be wrapped into a larger health-risk test offered by the company, only detects three out of more than 1 ...
The FDA says you can now test yourself for cancer at home without a doctor. Here's why you shouldn't.NBCNews.com

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03/23/2018 01:06 PM

The Pharma Letter

FDA approval of new indication for Tasigna
The Pharma Letter
Swiss pharma giant Novartis (NOVN: VX) got a boost late yesterday with an additional indication for its already blockbuster drug to treat children with a rare form of leukemia. The US Food and Drug Administration expanded the indication for Tasigna ...

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03/23/2018 10:56 AM


FDA Approves Nilotinib for Pediatric CML - OncLive
The FDA has approved nilotinib for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase.
Nilotinib Granted FDA Approval for Pediatric CML - Targeted OncologyTargeted Oncology
FDA Approves Tasigna for Pediatric CMLCuretoday.com
FDA expands approval of Tasigna for children with leukemia subtypeHealio
GlobeNewswire (press release) -PR Newswire (press release) -www.oncnursingnews.com/
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03/22/2018 05:00 PM