Vertex to Seek Expanded FDA Approval for Trikafta After Positive Child Safety Data
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is safe for use in children with cystic fibrosis (CF) as young as age 6, data...
Approval of drug therapy a 'new dawn' for cystic fibrosis care in Ireland
A drug which has the potential to treat the underlying cause of cystic fibrosis for 80% of patients in Ireland has been approved by the...
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 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...
Symdeko Approved in Australia for CF Patients Age 12 or Older With Certain Gene Mutations
Cystic fibrosis (CF) patients in Australia age 12 and older, who have two copies of the F508del mutation in the CFTR gene (a copy...
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...
Cystic fibrosis drug Orkambi 'approved for use among 6-11 year olds'
The pharmaceutical firm making cystic fibrosis drug Orkambi says it has received EU approval to treat children. Manufacturer Vertex says...
