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Home » Topics » Regulatory

Regulatory
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Waylivra receives conditional marketing authorization from the European Commission

May 8, 2019

FDA approves Ruzurgi for pediatric patients with Lambert-Eaton myasthenic syndrome

May 7, 2019

FDA approves Kadcyla for adjuvant treatment in HER2-positive early breast cancer setting

May 6, 2019

Qternmet XR approved in U.S. for type 2 diabetes

May 3, 2019

FDA approves Tibsovo for newly diagnosed IDH1 mutant AML ineligible for intensive chemotherapy

May 3, 2019

Kalydeco approved in U.S. for infants from 6 months with cystic fibrosis

May 2, 2019

FDA approves Mavyret for pediatric patients with HCV

May 2, 2019

FTC enforcement aside, disclosure is vital to trust for DTC gene testing firms

April 30, 2019
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has been active for some time in enforcement of its regulations for direct-to-consumer (DTC) gene testing firms, but Linda Malek, a partner at the New York office of Moses & Singer LLP, told BioWorld MedTech that while FTC compliance is becoming a bigger lift for DTC gene testing firms, the controversy in 2018 over a gene testing firm's sharing of data with a drug maker suggests that DTC gene testing companies might want to "hold yourself to an even higher standard in order to maintain trust in your product."
Read More

European Commission approves Zynquista for type 1 diabetes

April 29, 2019

FDA approves intravenous Benlysta for pediatric SLE

April 29, 2019
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