Denise Myshko

Articles by Denise Myshko

The FDA has made three approvals this week: a novel drug for dry eye disease, a new indication for Prevymis to prevent CMV disease in adult kidney transplant recipients, and another prostate cancer indication for Lynparza. The agency has also set target action dates for the first CRISPR gene edited therapy and a supplement indication for Jemperli for earlier treatment of endometrial cancer. Additionally, Janssen submitted sBLA for Carvykti for early treatment of myeloma.

FDA approvals this week include: novel treatment for invasive candidiasis, an accelerated approval to Zynyz for Merkel cell carcinoma, the high-concentration Humira biosimilar Hyrimoz, and extension of Evkeeza’s indication to include young children. The agency also issued two complete responses this week: for Incyte’s extended-release Jakafi and for AbbVie’s Parkinson’s therapy.

Although not a common complication of hip, knee and other metal implants, the number of allergic reactions is growing, partly the number of joint replacements is growing, according to a presentation at the annual meeting of the American Academy of Dermatology. Nickel is the most common contact allergen.