Cystic Fibrosis Foundation14d
FDA Approves New, Once-a-Day CFTR Modulator for People With CF
A new CFTR modulator treatment called Alyftrek has been approved for people with CF ages 6 and older who have CFTR mutations ...
Cystic Fibrosis Foundation14d
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 Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has ...
FiercePharma11d
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 ...
BioPharma Dive1d
10 clinical trials to watch in the first half of 2025
Expected readouts in diabetes, cancer and depression headline a series of study results that could help the biotechnology ...
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
MedCity News1d
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 decisions.
Morningstar14d
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis - ALYFTREK™ is approved for patients 6 years and older with at ...
Daily11d
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 ...
GlobalData on MSN11d
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.
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 ...
Nasdaq14d
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis
ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies - - In head-to-head ...