FDA ALERT
FDA ALERT
04/12/2024

Jessica Bard

Jessica Bard
The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...
04/12/2024
FDA alert
FDA alert
08/25/2023
Jessica Ganga
Following a multicenter clinical trial, a new treatment for pneumonia caused by Acinetobacter baumannii-calcoaceticus has been approved for use in adults.
08/25/2023
FDA Alert
FDA Alert
07/24/2023
Jessica Ganga
Following three clinical trials, the FDA has approved a new preventive treatment for neonates, infants, and toddlers that prevents respiratory syncytial virus (RSV) in those age populations.
07/24/2023
FDA ALERTS
FDA ALERTS
01/27/2023
Following a multicenter study, the FDA approved the combination of albuterol and budesonide—an inhaled corticosteroid—for the treatment of asthma in adults.
01/27/2023
Pneumonia
Pneumonia
06/05/2020
It is a new indication for the medication, which had already been FDA-approved for the treatment of patients with complicated UTIs and complicated intraabdominal infections who have limited or no...
06/05/2020
Pulmonary Fibrosis
Pulmonary Fibrosis
09/09/2019
Previously to this drug’s approval, there were no treatment options for adults with interstitial lung disease associated with systemic sclerosis or scleroderma.
09/09/2019
FDA
FDA
11/14/2018
The American Thoracic Society says the FDA approved the asthma treatment with lack of consideration for patient safety and for a public policy process.
11/14/2018
FDA
FDA
09/07/2017
The FDA has approved the first treatment option in the United States for patients age 3 years or older with congenital or idiopathic pulmonary arterial hypertension.
09/07/2017
FDA
FDA
05/18/2017
The US Food and Drug Administration has expanded the approval of a drug used to treat cystic fibrosis.
05/18/2017