Denise Myshko

Articles by Denise Myshko

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.

The FDA has approved a novel nasal spray for migraine and a generic leukemia treatment. The agency has granted priority review to Leqembi for traditional approval but extended the review of hemophilia A gene therapy. Regulators have also assigned target dates for Voxzogo in young children with dwarfism, a skin infection gel, a nerve disorder drug and for Jardiance in children 10 to 17 with diabetes.

The FDA has approved Kevzara for an inflammatory rheumatic disease and Skyclarys, the first therapy for rare neuromuscular disease. The agency set an action date for Opdivo for melanoma indication. An advisory committee has supported Pfizer’s RSV vaccine, and Janssen has submitted an NDA for combo tablet for metastatic prostate cancer.

The FDA approved several new therapies this week, including a weekly hemophilia A treatment, an extended-release version of Austedo, and the first drug for geographic atrophy due to AMD, as well as an accelerated approval to Filspari for rare kidney disease. The agency also indicated it will hold an advisory committee meeting on Onpattro for heart failure indication, granted priority review for Pfizer’s RSV vaccine and for a life-threatening hereditary immune disease, and also set goal date for blurry vision therapy.