Blog

A Patient’s Voice: Kathy’s Story

Your contribution will help fund NTMir’s work in education, advocacy and research.   Kathy’s Story “One step at a time. One punch at a time. One round at a time.” Kathy Norris, 53 is a fighter and dedicated mother of two. She, uses this quote to describe how she approaches her struggle with Nontuberculous Mycobacteria […]

FDA Workshop on the Development of Antibiotic Therapies for NTM

The FDA workshop on “The Development of Antibiotics for the Treatment of NTM Disease” on April 8, 2019 was very successful, with more than 100 people attending in person. The agenda focused on issues surrounding clinical trials and the development of a validated Patient-Reported Outcome (PRO) tool. Panelists included experts in NTM and in PRO, […]

NTM Patient Preferences Survey

On April 8th, 2019 the U.S. Food & Drug Administration will host a public workshop on the development of antibacterial drugs for the treatment of nontuberculous mycobacterial (NTM) infection. At this workshop, we will convey patient experiences and preferences. Ahead of the workshop, we have published a survey to gather more information about patient preferences. […]

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 to discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic […]

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 about the unmet needs for bronchiectasis patients. You told them your […]