As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
Vertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people ...
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...
The task ahead of Vertex now is to migrate patients already on Trikafta to the new drug. That is supported by data from the ...
Additionally, the prescribing information for Trikafta has been updated with a boxed warning regarding drug-induced liver injury and liver failure. The boxed warning states liver function ...
The drug is also eligible for use in CF patients who have discontinued Trikafta or Vertex’s other CF medicines. Similar regulatory filings are also under review in Europe. However, the drug’s ...