FDA to Review sBLA for Jemperli for Earlier Treatment of Endometrial Cancer
The FDA has assigned an action date of Sept. 23, 2023. If approved, this would be the first frontline treatment advancement in decades for patients with advanced or recurrent endometrial cancer.
New Heart Failure Drug Likely to be Cost-Effective in Hospitalized Patients
In an analysis, researchers determined that Inpefa is cost-effective at commonly accepted willingness-to-pay thresholds in treating patients with heart failure who have diabetes.
FDA Approves Prevymis for CMV Prevention in Kidney Transplant Patients
Prevymis was approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant in 2017.
FDA Clears Lynparza for Prostate Cancer with High Mortality Risk
The combination of Lynparza and abiraterone reduced the risk of disease progression or death by 76% vs. abiraterone alone in patients with BRCA-mutated metastatic castration-resistant prostate cancer.
CMS Will Cover Alzheimer’s Drugs Leqembi, Donanemab — With Strings Attached
The drugs must have full “traditional” FDA approval and patients need to be enrolled in a registry that collects post-approval data efficacy and safety when the drugs are used in clinical practice.
Coherus Announces Lowest Price for Humira Biosimilar, Partners with Mark Cuban Cost Plus
Coherus will launch Yusimry in July with a list price of $995 per carton (2 x 40 mg/0.8 mL autoinjectors); “the lowest price announced to date of any adalimumab offering in the United States,” the company said.
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