Review of agents in late-stage development for the treatment of asthma (November 2005).
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
FDA Accepts sNDA for Ofev in Children with Rare Lung Disease
If approved, Ofev would be the first approved treatment for children and adolescents with fibrosing interstitial lung disease. A decision is expected in the fourth quarter of this year.
FDA Approves Tezspire in Pre-Filled Pen
Tezspire is a biologic that specifically targets the inflammation associated with asthma.
FDA Approves Rescue Combination Medication for Asthma
Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.
FDA Accepts BLA for RSV Prevention in Infants
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
FDA Accepts for Priority Review BLA for RSV Vaccine
If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.
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