Agents in late-stage development for the treatment of asthma, COPD, and PAH
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.
FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis
With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.
FDA Approves First Interchangeable Biosimilar to Lucentis
Coherus’ Cimerli has been approved to be interchangeable for all five indications, including age-related macular degeneration and diabetic retinopathy. It will be available in early October 2022.
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