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Lung Transplant Foundation, FDA Confer About BOS

The Lung Transplant Foundation is hosting a meeting with the U.S. Food and Drug Administration (FDA) with the intent of educating the agency and public about the challenges of living with bronchiolitis obliterans syndrome (BOS), a severe complication of lung transplants. “This is the first time that regulators and policymakers…

Azithromycin Has Some Benefits for CF Infants, Study Shows

Treatment with the antibiotic azithromycin did not prevent the development of lung damage in infants with cystic fibrosis (CF), but was safe and lowered inflammation, hospital stays and antibiotic usage, according to data from a Phase 3 clinical trial. “Azithromycin treatment from diagnosis of cystic fibrosis after newborn…

FDA Grants Lupin Tentative Approval for Ivacaftor Generic

Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) to market ivacaftor tablets, a generic version of the cystic fibrosis (CF) therapy Kalydeco. The company’s request came in the form of an abbreviated new drug application (ANDA), containing data submitted for review and approval…

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