clinicaladvisor.com1 天
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.
Pharmaceutical Technology4 天
Navocaftor by Sionna Therapeutics for Cystic Fibrosis: Likelihood of Approval
Navocaftor is under clinical development by Sionna Therapeutics and currently in Phase II for Cystic Fibrosis.
Pharmaceutical Technology4 天
SION-2851 by Sionna Therapeutics for Cystic Fibrosis: Likelihood of Approval
SION-2851 is under development for the treatment of cystic fibrosis. It is a small molecule administered orally. It is a first generation corrector. The drug candidate targets cystic fibrosis ...
FiercePharma11 天
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from ...
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
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.
The Pharma Letter11 天
Vertex nabs FDA approval for Alyftrek and Trikafta
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations.
Vertex' Trikafta Gets Expanded FDA Approval For Cystic Fibrosis Treatment
Vertex Pharmaceuticals (VRTX) said Friday the U.S. Food and Drug Administration expanded its approval of a cystic fibrosis treatment, ...
Vertex's Cystic Fibrosis Drug Alyftrek Gets FDA Approval
(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) Friday announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek for treatment of cystic fibrosis.
Cystic Fibrosis Foundation13 天
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 ...
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 ...
Vertex Gains FDA Approval for Cystic Fibrosis Drug Alyftrek
Alyftrek is Vertex's fifth CFTR modulator to secure FDA approval. It is also under regulatory review in the European Union, the United Kingdom, Canada, Switzerland, Australia and New Zealand. Write to ...
Le Lézard13 天
Vertex Announces US FDA Approval of ALYFTREKtm, a Once-Daily Next-in-Class CFTR Modulator ...
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple ...