FDA Panel Votes in Favor of Nirsevimab for RSV Disease Prevention in Infants
If approved by the third quarter of 2023, the Company expects to make nirsevimab available for the 2023 to 2024 RSV season.
If approved by the third quarter of 2023, the Company expects to make nirsevimab available for the 2023 to 2024 RSV season.
The study included 1458 children aged 5 to 11 years with a clinical history of HDM-induced allergic rhinitis.
FDA revoke Emergency Use Authorization for COVID-19 vaccine; New approval for treatment of iron deficiency in patients with heart failure; Lumryz now available for excessive daytime sleepiness; Vowst approved for C. difficile infection; Prevymis approved for prophylaxis of CMV disease in adult kidney transplant recipients.
47.7 percent of those ≥16 years had hybrid immunity, with the lowest prevalence seen for adults aged ≥65 years.
Vevye is cyclosporine, solubilized in a novel, water-free excipient.
The sBLA is supported by data from the KEYNOTE-966 trial.
RP-A601 is an investigational adeno-associated virus-based gene therapy.
The RECELL System is a single-use, autologous cell harvesting device.
Adding the mRNA-4157 vaccine to pembrolizumab improved recurrence-free and distant metastasis-free survival in patients with high-risk, resected melanoma in a phase 2 trial.
Most NCCN cancer centers have been affected by shortages of the chemotherapy drugs carboplatin and cisplatin, a survey suggests.