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

RTTNews | Pred 1146 dňami
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.

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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 | Pred 1145 dňami
European Economic News Preview: UK Unemployment Data Due

European Economic News Preview: UK Unemployment Data Due

Unemployment from the UK and economic confidence from Germany are the top economic news due on Tuesday. At 2.00 am ET, the Office for National Statistics publishes UK unemployment data. The jobless rate is forecast to remain unchanged at 4.7 percent in the second quarter. At 3.00 am ET, retail sales figures are due from Turkey.
RTTNews | Pred 3 h 16 min
Australian Market Trims Early Gains In Mid-market

Australian Market Trims Early Gains In Mid-market

The Australian stock market is trimming its early gains in mid-market trading on Tuesday, but extending the gains in the previous session, despite the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving above the 8,850 level to fresh all-time high, with gains in financial and energy stocks partially offset by weakness in mining and technology stocks.
RTTNews | Pred 4 h 52 min
Asian Markets Trade Mostly Higher

Asian Markets Trade Mostly Higher

Asian stock markets are trading mostly higher on Tuesday, despite the broadly negative cues from Wall Street overnight, with the Australian and the Japanese markets hitting record all-time highs, as the U.S. and China agreed to extend their tariff truce for another 90 days. Optimism about the US Fed cutting interest rate at its next meeting is also aiding market sentiment.
RTTNews | Pred 5 h 31 min