BioPharma Dive13m
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
clinicaladvisor.com2h
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
Cystic Fibrosis Foundation12d
FDA Approves Trikafta for 94 Additional Rare CFTR Mutations
The U.S. Food and Drug Administration (FDA) today approved the expansion of Trikafta (elexacaftor/tezacaftor/ivacaftor) to ...
FiercePharma10d
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
Cystic Fibrosis Foundation12d
FDA Approves New, Once-a-Day CFTR Modulator for People With CF
A new CFTR modulator treatment called Alyftrek has been approved for people with CF ages 6 and older who have CFTR mutations ...
Hosted on MSN12d
Vertex Wins An Early Approval; Why It Might Not Move Vertex's Beleaguered Stock
The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late ...
BioSpace10d
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...
Why This Beaten-Down Growth Stock Is a No-Brainer Buy on the Dip
The medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...
Business Wire13d
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA ® (elexacaftor ...
Monthly Prescribing Reference6d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to <12 years and less than 30kg: morning dose of elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg ...