News

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…

Reducing Trikafta Dose May Ease Mental Side Effects, Study Reports

Instead of stopping Trikafta treatment, reducing the dose and providing psychological support may reduce or resolve mental health side effects, including depression, anxiety, and brain fog in patients with cystic fibrosis (CF), a new study reports. “It was reassuring that dose adjustments, in conjunction with psychological support and…

PP-007 Resolves Lung Inflammation in CF Mouse Model

Treatment with PP-007 — a compound known to promote the release of anti-inflammatory carbon monoxide (CO) gas — significantly reduced the levels of pro-inflammatory immune cells and molecules in the lungs of a mouse model of cystic fibrosis (CF), a study shows. These benefits were associated with an increased production…

Study: Most CF Infants Had Healthy Stools in First Year

Stool consistency and frequency were healthy for the majority of infants with cystic fibrosis (CF) in the first year of life, according to an analysis of data from the BONUS study. Stool consistency and frequency were not associated with pain, while infants exclusively fed with formula or who received…