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

RTTNews | vor 1045 Tagen
Stocktwits
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.

Tags: AMYT
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Additional Upside Seen For Singapore Stock Market

Additional Upside Seen For Singapore Stock Market

The Singapore stock market has moved higher in back-to-back sessions, advancing almost 40 points or 1.1 percent along the way. The Straits Times Index now sits just above the 3,845-point plateau and it's likely to open to the upside again on Monday.
RTTNews | vor 29 Minuten
Malaysia Stock Market May Extend Winning Streak

Malaysia Stock Market May Extend Winning Streak

The Malaysia stock market has moved higher in two straight sessions, collecting more than 25 points or 1.6 percent along the way. The Kuala Lumpur Composite Index now sits just above the 1,540-point plateau and it may add to its winnings again on Monday.
RTTNews | vor 59 Minuten
Indonesia GDP Data Due On Monday

Indonesia GDP Data Due On Monday

Indonesia will on Monday release Q1 figures for gross domestic product, highlighting a light day for Asia-Pacific economic activity.
RTTNews | vor 1Std 59 Minuten
U.S. Dollar Recovers After Jobs Data

U.S. Dollar Recovers After Jobs Data

The U.S. dollar rebounded against its major counterparts in the New York session on Friday, after the release of better-than-expected non farm payrolls report for April.
RTTNews | vor 2 Tagen
Swiss Market Ends On Bright Note

Swiss Market Ends On Bright Note

The Switzerland market closed on a strong note on Friday, mirroring the trend in markets across Europe and elsewhere, as worries about trade tensions eased after China stated its willingness to hold talks with the U.S.
RTTNews | vor 2 Tagen
European Stocks Close On Buoyant Note

European Stocks Close On Buoyant Note

European stocks closed higher on Friday, with the major markets in the region posting strong gains, amid easing concerns about U.S-China trade relations, and on upbeat U.S. non-farm payroll data.
RTTNews | vor 2 Tagen
Canadian Market Up Firmly In Positive Territory

Canadian Market Up Firmly In Positive Territory

The Canadian market is up firmly in positive territory a little past noon on Friday, amid easing concerns about U.S.-China trade tensions following China expressing willingness to hold tariff talks with the United States. Data showing a much higher than expected increase in U.S. non-farm payroll growth in the month of April is also aiding sentiment.
RTTNews | vor 2 Tagen
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