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Home » Topics » Regulatory

Regulatory
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Vyndaqel approved in Japan for transthyretin amyloid cardiomyopathy

March 26, 2019

Japan first to approve Skyrizi for psoriasis indications

March 26, 2019

Smyraf approved in Japan to treat rheumatoid arthritis

March 26, 2019

European Commission approves Forxiga for type 1 diabetes

March 25, 2019

FDA approves Sunosi for excessive daytime sleepiness associated with narcolepsy or OSA

March 21, 2019

FDA approves Zulresso for postpartum depression

March 20, 2019

FDA approves Tecentriq with chemotherapy for first-line treatment of extensive-stage SCLC

March 19, 2019

FDA approves sNDA for Avycaz for pediatric patients with cUTI and cIAI

March 19, 2019

FDA approves Rocklatan to reduce IOP in open-angle glaucoma or ocular hypertension

March 13, 2019

FDA approves Spravato for treatment-resistant depression

March 6, 2019
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