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Home » Topics » Regulatory

Regulatory
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FDA gives nod to Theranica's wearable for the acute treatment of migraine pain

May 30, 2019
By Liz Hollis
Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.
Read More

FDA approves sNDA for Vraylar for bipolar depression

May 28, 2019

FDA approves Piqray for HR+/HER2-, PIK3CA-mutated advanced breast cancer

May 27, 2019

Jakafi approved by FDA for steroid-refractory acute GvHD

May 27, 2019

FDA approves Zolgensma for spinal muscular atrophy

May 27, 2019

Actemra approved in Japan for adult-onset Still's disease

May 23, 2019

FDA approves Venclexta with Gazyva for previously untreated CLL or SLL

May 16, 2019

FDA approves Bavencio with Inlyta for advanced renal cell carcinoma

May 15, 2019

FDA approves Eylea to treat all stages of diabetic retinopathy

May 14, 2019

FDA approves Cyramza for hepatocellular carcinoma previously treated with sorafenib

May 13, 2019
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