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FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...
Hosted on MSN17d
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 ...
clinicaladvisor.com4d
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.
Should You Buy Vertex Pharmaceuticals on the Dip Before Potentially Enormous News in January 2025?
Different genetic mutations cause different problems with this particular protein -- so CFTR modulators generally don't work ...
Business Wire17d
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 ...
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 ...
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 ...
FiercePharma14d
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 chalked up a win in its specialty area of cystic fibrosis. The FDA has ...
How hockey became a lifeline for Gunnar and Boomer Esiason
Throughout Gunnar Esiason's journey with cystic fibrosis, the sport of hockey has always been huge part of his family. See ...
STAT25d
South African regulator decides Vertex provides sufficient access to CF drugs, angering activists
generic versions of Trikafta, a particularly effective triple-combination treatment for the disease, which causes the body to produce thick, sticky mucus that damages the lungs and other organs.
Daily15d
FDA approves Alyftrek once-daily oral combination for cystic fibrosis
The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and ...
Monthly Prescribing Reference11d
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 ...