clinicaladvisor.com5d
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.
Hosted on MSN14d
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
FiercePharma15d
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 ...
Jeremy Schaap calls Boomer and Gunnar Esiason E:60 ‘one of the best things we’ve done’
Boomer and Gunnar Esiason’s work to find a medical miracle against cystic fibrosis is a story Jeremy Schaap is excited to ...
MarketWatch17d
Vertex Gets Expanded FDA Approval for Cystic Fibrosis Treatment
Vertex Pharmaceuticals said Friday the U.S. Food and Drug Administration expanded its approval of a cystic fibrosis treatment, encompassing more patients with different types of mutations of the ...
BioPharma Dive5d
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 ...
Business Wire18d
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
“Since its first approval in 2019, TRIKAFTA has had a transformative impact on tens of thousands of people living with cystic fibrosis,” said Carmen Bozic, M.D., Executive Vice ...
MedPage Today18d
Next-in-Class Once-Daily Pill Approved for Cystic Fibrosis
Share on Facebook. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved a once-daily oral combination of ...
Investing18d
FDA expands approval for cystic fibrosis drug Trikafta
TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR ...
STAT25d
South African regulator decides Vertex provides sufficient access to CF drugs, angering activists
After a lengthy investigation, South African regulators decided Vertex Pharmaceuticals has sufficiently provided access to its cystic fibrosis medications ... versions of Trikafta, a particularly ...
Yahoo Finance15d
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Vertex is also evaluating Alyftrek in children with cystic fibrosis aged 2 to 5 years ... Vertex announced that the FDA has expanded Trikafta’s label to include an additional 94 non-F508del ...
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 ...