News

Respinova’s Pulsehaler Device Wins FDA OK

Respinova’s non-invasive Pulsehaler, a medical device meant to ease breathing in patients with airway restrictions, such as in cystic fibrosis (CF), has been cleared for marketing in the U.S. Pulsehaler was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) following the company’s submission of a…

Life Edit Will Use CFF Award to Explore Gene-editing Technology

The Cystic Fibrosis Foundation (CFF) is awarding Life Edit Therapeutics up to $400,000 to explore its new gene-editing technology to develop treatments for certain patients with cystic fibrosis (CF) who cannot benefit from existing medicines. “We’re looking forward to working with the CF Foundation to leverage the unique…

CHMP Favors Kaftrio to Treat CF Patients in EU Starting at Age 12

A European Medicines Agency (EMA) committee favors extending the label for Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with Kalydeco (ivacaftor), to treat cystic fibrosis (CF) patients 12 and older who have at least one copy of the CFTR gene with an F508del mutation. The European Commission (EC) approved the same combination last year…