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 ...
FiercePharma10d
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 ...
Vertex Pharmaceuticals: Alyftrek Is An 'Accretive Opportunity' On Top- And Bottom-Lines, Says Bullish Analyst
Vertex Pharmaceuticals announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...
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 ...
clinicaladvisor.com7d
Alyftrek Gets FDA Approval for Cystic Fibrosis
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 ...
Monthly Prescribing Reference10d
Alyftrek Gets FDA Approval for Cystic Fibrosis
Findings showed treatment with Alyftrek was noninferior to ELX/TEZ/IVA in absolute change from baseline in ppFEV1 at week 24 in both SKYLINE trials. In both trials, participants received oral ELX ...
Daily10d
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 ...
Zacks.com on MSN10d
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
The FDA's nod is based on late-stage data, which show that treatment with VRTX's Alyftrek enhances patient benefit compared ...
Cystic Fibrosis Foundation12d
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 ...
BioSpace10d
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...
Morningstar13d
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 ...