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FDA Grants Priority Review to Vertex’s 1st Triple Combo for CF

The U.S. Food and Drug Administration (FDA) has granted priority review to Vertex’s new drug application for its triple combination —...

Pharmaxis hopeful of FDA approval for cystic fibrosis inhalation medicine Bronchitol by Q1 2020

Pharmaxis Ltd (ASX:PXS) chief executive officer Gary Phillips updates Proactive Investors on the FDA approval timeframe for the company’s...

FDA Grants Orphan Drug Status to AR-501, Potential CF Treatment for Chronic Lung Infections

AR-501, an investigational inhaled formulation of gallium citrate to treat chronic lung infections in patients with cystic fibrosis (CF),...

FDA Approves Symdeko for Treatment of CF Children, Ages 6 to 11, with Certain CFTR Mutations

The U.S. Food and Drug Administration (FDA) has approved Symdeko (tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of...

FDA Approves Kalydeco for Treatment of 6- to 12-month-old Infants with Cystic Fibrosis

The U.S. Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) for the treatment of infants from six to 12 months old, who...

Toddlers Age 1-2 With CF Can Now Be Treated With Kalydeco in Canada

Health Canada has approved the use of Kalydeco (ivacaftor) in toddlers age 1-2 years with certain genetic mutations that prevent the...

FDA puts Translate Bio’s rare disease mRNA drug on hold

The FDA has placed a clinical hold on the IND for Translate Bio’s mRNA treatment for ornithine transcarbamylase (OTC) deficiency, a...

FDA Approves AzurRx Biopharma Request to Test MS1819-SD in CF Patients with EPI

AzurRx BioPharma is planning a multi-center Phase 2 trial to be conducted in the United States and Europe to evaluate its lead candidate...

FDA Expands Kalydeco’s Approval to 1-year-old Toddlers with Cystic Fibrosis

The U.S. Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) as the first-ever therapy to treat the underlying cause of...

Vertex Wins FDA Approval for Expanded Cystic Fibrosis Treatment

Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) shares saw a handy gain on Thursday after the U.S. Food and Drug Administration (FDA) gave the...

Disease Duration, Flare-ups Affect Mental Health of Non-CF Bronchiectasis Patients, Study Finds

VERTEX’S CF BLOCKBUSTER TRIKAFTA EFFECTIVE IN KIDS 6 TO 11 YEARS OF AGE

A case for improved carrier screening

Vertex to Seek Expanded FDA Approval for Trikafta After Positive Child Safety Data

Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS

Age May Affect Outcomes in Lung Transplant Recipients With Cystic Fibrosis

CFF Funding Will Further ContraFect’s Research Into Alternative for Antibiotics

The search for molecular glue in targeted disease control

Vest Therapy Lowers Risk of Hospitalization in Non-CF Bronchiectasis, Study Says

Harvard is working with Boston hospitals to test existing cystic fibrosis drug to help coronavirus p