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

RTTNews | 1046 days ago

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

(RTTNews) - 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).

EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US Food and Drug Administration (FDA) to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt's NDA for Oleogel-S10.

Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA's Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

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

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

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.

RTTNews | 1047 days ago

DAX Extending Recent Gains

DAX Extending Recent Gains

German stocks are up in positive territory on Monday, gaining for a ninth straight session, as investors continue to react to corporate earnings, and monitor developments on the trade front. Markets also await the monetary policy announcements from the Federal Reserve and the Bank of England, due later in the week.

RTTNews | 10 minutes ago

Tomatoes Supplied By H&C Farms In 14 States Recalled For Salmonella Concern

Tomatoes Supplied By H&C Farms In 14 States Recalled For Salmonella Concern

The U.S. Food and Drug Administration has announced the recalls of Vine Ripe Tomatoes in 14 states, supplied by Hanshaw & Capling or H&C Farms, and repacked and sold by various companies, citing the potential to be contaminated with Salmonella, a bacteria that causes the foodborne illness salmonellosis. Immokalee, Florida -based H&C Farms initiated the recall due to the possible presence...

RTTNews | 21 minutes ago

European Shares Mostly Higher As Investors Look Ahead To Fed, BoE Meetings

European Shares Mostly Higher As Investors Look Ahead To Fed, BoE Meetings

European shares traded mostly higher on Monday as investors awaited new updates on the tariff front and looked ahead to interest rate decisions from the Federal Reserve and the Bank of England, due later this week.

RTTNews | 58 minutes ago

NZ Dollar Advances Against Most Majors

NZ Dollar Advances Against Most Majors

The New Zealand dollar strengthened against most major currencies in the late Asian session on Monday.

RTTNews | 1h 45min ago

Australian Dollar Rises Against Majors

Australian Dollar Rises Against Majors

The Australian dollar strengthened against other major currencies in the late Asian session on Monday.

RTTNews | 1h 49min ago

Asian Shares Mixed In Thin Holiday Trade

Asian Shares Mixed In Thin Holiday Trade

Asian stocks ended mixed in thin trade on Monday after U.S. President Donald Trump said he had no plans to talk to his Chinese counterpart this week.

RTTNews | 2h 16min ago

European Shares Poised For Lower Open

European Shares Poised For Lower Open

European stocks may open broadly lower on Monday, with regional volumes likely to remain thin due to a bank holiday in the U.K.

RTTNews | 4h 28min ago

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