Vertex's (VRTX.US) new generation small molecule combination therapy has received FDA and EMA approval for market application.

It is reported that the Zhitongcaijing APP learned that Vertex Pharmaceuticals (VRTX.US) announced that the U.S. FDA has accepted its new drug application (NDA) for once-daily vanczaftor/tezacaftor/deutivacaftor triple therapy (Vanza Triple Therapy) for the treatment of cystic fibrosis (CF) patients aged 6 and above. These patients have at least one F508del mutation or another responsive mutation in the CFTR gene. Patients with these mutations respond to Van

Zhitong FinanceJul 2 22:07 ET

FDA Accepts Vertex Pharmaceuticals' New-Drug Application for Combination Therapy to Treat Cystic Fibrosis

Vertex Pharmaceuticals (VRTX) said Tuesday that the US Food and Drug Administration has accepted its new-drug application for the combination therapy of vanzacaftor, tezacaftor, and deutivacaftor to t

MT NewswiresJul 2 09:25 ET

Vertex Gets Speedy FDA Review of Vanza Triple Cystic Fibrosis Therapy

By Colin Kellaher Vertex Pharmaceuticals has won Food and Drug Administration priority review for its application seeking approval of a triple combination therapy for the genetic lung disease cystic

WSJJul 2 08:59 ET

Express News | Vertex Pharmaceuticals Announces FDA Acceptance Of NDA For Vanza Triple Therapy With Priority Review, PDUFA Target Date Set For January 2, 2025; EU Marketing Authorization Application Also Validated By EMA For Cystic Fibrosis Treatment

BenzingaJul 2 08:34 ET

Express News | Vertex Pharmaceuticals Inc: EU Marketing Authorization Application (Maa) Submission Validated by EMA

ReutersJul 2 08:33 ET

Express News | Vertex Pharmaceuticals Inc: Vanza Triple Granted Priority Review With Prescription Drug User Fee Act (Pdufa) Target Action Date of January 2, 2025

ReutersJul 2 08:33 ET