Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...

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 announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...

The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late ...

The medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...

The Food and Drug Administration (FDA) has approved Alyftrek ™ (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one ...

The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and ...

In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV 1 and further decreased sweat chloride compared to TRIKAFTA ® - BOSTON, December 20, 2024--(BUSINESS WIRE)--Vertex ...

After Vertex Pharmaceuticals (VRTX) announced early FDA approval of Alyftrek in cystic fibrosis ahead of a PDUFA deadline on January 2, ...

The drug will be marketed under the brand name Alyftrek. Post the FDA’s approval, the orally administered Alyftrek has been approved for use in CF patients aged six years and older who have at ...

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 ...

Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis ...