-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation- -Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range- BOSTON --(BUSINESS WIRE)--Jun.
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
FDA Grants Fast Track Designation to Vertex’s Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 Cambridge, MA, December 8, 2005 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 Cambridge, MA, December 8, 2005 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to
-- Six-month review date of April 18, 2012 set by FDA -- -- European Medicines Agency accepts KALYDECO regulatory submission for accelerated assessment -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S.
Federal Court Orders Dismissal of Shareholder Lawsuit Against Vertex Pharmaceuticals Cambridge, MA, February 23, 2005 --Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the United States District Court for the District of Massachusetts has granted its motion to dismiss a
- Mean absolute improvement in lung function of 6.1 percentage points within group (p < 0.001) and 8.6 percentage points compared to placebo (p < 0.001) in homozygous patients receiving combination treatment (Day 28 to 56) with highest study dose of VX-809 (600mg) - - Adverse events were
