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

RTTNews | 1134 days ago
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 | 1133 days ago
Australian Market Maintains Early Losses In Mid-market

Australian Market Maintains Early Losses In Mid-market

The Australian stock market is maintaining its early losses in mid-market moves on Friday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling below the 8,700 level, with weakness across most sectors led by energy and technology stocks.
RTTNews | 47 minutes ago
Asian Markets Mixed Amid Tariff Uncertainty

Asian Markets Mixed Amid Tariff Uncertainty

Asian stock markets are trading mixed on Friday, following the broadly negative cues from Wall Street overnight, as uncertainty over US reciprocal tariffs still lingers with less than a day remaining for the crucial deadline for negotiations to reach a trade deal expires. US President Donald Trump's revised tariffs on several countries lacking deals are set to be fixed between 10 and 41 percent.
RTTNews | 1h 7min ago
Japanese Market Notably Lower

Japanese Market Notably Lower

Reversing the gains in the previous session, the Japanese market is notably lower on Friday, following the broadly negative cues from Wall Street overnight. The Nikkei 225 is falling below the 40,700 level, with weakness in financial and technology stocks partially offset by gains in exporters and automaker stocks.
RTTNews | 2h 43min ago
Australian Market Notably Lower

Australian Market Notably Lower

The Australian stock market is trading notably lower on Friday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling below the 8,700 level, with weakness across most sectors led by energy and technology stocks.
RTTNews | 2h 45min ago
Swiss Market Ends Moderately Lower

Swiss Market Ends Moderately Lower

Despite a decent spell in positive territory till about an hour before noon, the Switzerland market turned weak and kept drifting lower as the session progressed on Thursday to eventually settle with a moderate loss.
RTTNews | 10h 33min ago