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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.

Cuban, of "Shark Tank' fame and owner of the Dallas Mavericks, called drugs prices ‘insane’ and used some profanity when talking pharmacy benefit managers at the annual meeting of the Association for Accessible Medicines yesterday. Cuban has co-founded an online pharmacy that he says will make drug prices lower and transparent.

The FDA has approved two pediatric indications this week: Takhyzro for hereditary angioedema and Eylea for retinopathy of prematurity. The agency expanded the label of Cibinqo for atopic dermatitis in adolescents, and granted full approval to Jemperli for endometrial cancer. Additionally, the agency has set PDUFA dates for two drugs: reproxalap for dry eye and zuranolone for depression.

Our guest on this month’s episode of the “What's on Your Mind” podcast is Margaret Murray, M.P.A., founding CEO of the Association for Community Affiliated Plans (ACAP) and a longtime member of Managed Healthcare Executive® editorial advisory board. Murray is an expert on Medicaid and healthcare policies that affect people with low incomes. In the interview with Managing Editor of MHE, Peter Wehrwein, she discusses ACAP’s growth and its legislative wins, Medicaid redetermination, “junk insurance,” and state Medicaid programs carving out pharmacy benefits.

The FDA has approved two breast cancer therapies this week: Trodelvy to treat patients with HR+/HER2- breast cancer and Orserdu to treat patients with ER+, HER2-, ESR1-mutated disease. The agency also approved a novel therapy for CKD-related anemia and Tezspire in pre-filled pen.