Regulatory Updates

Latest News

FDA Approves First Treatment for Rare Immunodeficiency Disease
FDA Approves First Treatment for Rare Immunodeficiency Disease

March 27th 2023

Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.

FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years

March 24th 2023

FDA Rejects NDA for Extended-Release Jakafi
FDA Rejects NDA for Extended-Release Jakafi

March 24th 2023

FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma

March 23rd 2023

Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA

March 22nd 2023

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