FDA Workshop on Bronchiectasis Drug Development

The Food and Drug Administration is convening a public workshop titled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis” on Wednesday, June 27th from 8:30pm to 4:30pm ET. The purpose of this workshop is...

UPDATE: FDA Decision on Linhaliq

Aradigm, the company that submitted Linhaliq to the FDA for approval, announced that they had received a complete response letter (CRL) from the FDA stating that they would not approve the treatment at this time. Many of you have communicated recently with the FDA...

Getting Engaged: The Patient Voice

by Amy Leitman   At the end of June I attended DIA 2016, the annual conference for the Drug Information Association, as part of their Patient Advocacy Fellowship Program. The Fellowship Program is a major initiative designed to build industry awareness of the...