Respiratory

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FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension

September 28th 2023

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
FDA Accepts sNDA for Ofev in Children with Rare Lung Disease

July 25th 2023

FDA Approves Tezspire in Pre-Filled Pen
FDA Approves Tezspire in Pre-Filled Pen

February 3rd 2023

FDA Approves Rescue Combination Medication for Asthma
FDA Approves Rescue Combination Medication for Asthma

January 11th 2023

FDA Accepts BLA for RSV Prevention in Infants
FDA Accepts BLA for RSV Prevention in Infants

January 5th 2023

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