Clinical

Articles

Tezspire is a biologic that specifically targets the inflammation associated with asthma.

FDA Approves Tezspire in Pre-Filled Pen

Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.

FDA Approves Rescue Combination Medication for Asthma

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 BLA for RSV Prevention in Infants

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 Accepts for Priority Review BLA for RSV Vaccine

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

 FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

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.

FDA Approves First Interchangeable Biosimilar to Lucentis

Two studies conducted by AllianceRx Walgreens Prime call attention to the importance of adherence for reducing risk of negative health outcomes and financial costs.

Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs

Tyvaso DPI is a dry inhalation powder and new inhalation device to treat patients with pulmonary arterial hypertension, a life-threatening disease. It is expected to be available in June 2022.

FDA Approves New Formulation of Tyvaso

Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.

FDA Approves First Generic of Symbicort for Asthma and COPD

The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.

Respiratory