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Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

RTTNews | 1139天前

Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

(RTTNews) - Biopharmaceutical company Amryt Pharma plc (AMYT) announced the European Commission (EC) approval of Filsuvez in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.

EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

The EC approval of Filsuvez is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

標籤: AMYT

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Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).

RTTNews | 1138天前

U.S. Trade Deficit Narrows To $60.2 Billion In June As Imports Plunge

U.S. Trade Deficit Narrows To $60.2 Billion In June As Imports Plunge

The U.S. trade deficit narrowed by slightly more than anticipated in the month of June, according to a report released by the Commerce Department on Tuesday. The Commerce Department said the trade deficit shrank to $60.2 billion in June from a revised $71.7 billion in May.

RTTNews | 20分鐘前

U.S. Trade Deficit Narrows Slightly More Than Expected In June

U.S. Trade Deficit Narrows Slightly More Than Expected In June

The U.S. trade deficit narrowed by slightly more than anticipated in the month of June, according to a report released by the Commerce Department on Tuesday.

RTTNews | 1小時25分鐘前

Eurozone Private Sector Continues To Expand

Eurozone Private Sector Continues To Expand

Euro area private sector remained in the expansionary territory in July but the rate of growth remained sluggish as stagnant demand pulled back production, final survey results of the purchasing managers' survey by S&P Global showed on Tuesday. The HCOB composite output index rose to 50.9 in July from 50.6 in June. The flash reading was 51.0. A score above 50.0 indicates expansion.

RTTNews | 1小時27分鐘前

Bay Street May Open Slightly Higher

Bay Street May Open Slightly Higher

Canadian stocks may open on a positive note Tuesday morning amid expectations of a rate cut by the Federal Reserve next month. The focus will be on trade talks between Canad and Mexico.

RTTNews | 1小時39分鐘前

FTSE 100 Advances On Upbeat Earnings

FTSE 100 Advances On Upbeat Earnings

The UK market is modestly higher on Tuesday, extending gains from previous session, thanks to some upbeat corporate earnings announcements, and expectations that the Federal Reserve will cut interest rate in the near future to spur economic growth.

RTTNews | 2小時8分鐘前

Pound Rises As Traders Await BoE Monetary Policy Meeting

Pound Rises As Traders Await BoE Monetary Policy Meeting

The British pound strengthened against other major currencies in the European session on Tuesday, as traders shift their focus to the Bank of England's (BoE) monetary policy announcement on Thursday.

RTTNews | 2小時18分鐘前

CAC 40 Modestly Higher

CAC 40 Modestly Higher

The French stock market is modestly higher Tuesday afternoon with investors mostly reacting to earnings updates and a mixed batch of regional economic data. Expectations of a rate cut by the Federal Reserve sometime soon aid sentiment a bit.

RTTNews | 2小時39分鐘前

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