SPOTLIGHT -
Anticholinergic approved for COPD
FDA Approves First Treatment for Rare Immunodeficiency Disease
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
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
FDA Rejects NDA for Extended-Release Jakafi
Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
