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

RTTNews | hace 894
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.

read more
Win Streak May Continue For Indonesia Stock Market

Win Streak May Continue For Indonesia Stock Market

The Indonesia stock market has climbed higher in back-to-back sessions, gathering almost 280 points or 3 percent in that span. The Jakarta Composite Index now sits just above the 7,325-point plateau and it may add to its winnings on Thursday.
RTTNews | hace 5h 35min
Australian Market Modestly Higher

Australian Market Modestly Higher

The Australian market is trading modestly higher on Thursday, recouping the losses in the previous session, following the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving up to just below the 8,500 level, with gains in gold miners, technology and financial stocks partially offset by weakness in iron miners and energy stocks.
RTTNews | hace 5h 39min
Hong Kong Shares May Bounce Higher On Thursday

Hong Kong Shares May Bounce Higher On Thursday

The Hong Kong stock market on Wednesday ended the three-day winning streak in which it had collected almost 380 points or 2 percent. The Hang Seng Index now sits just above the 19,740-point plateau although it may find renewed support on Thursday.
RTTNews | hace 5h 50min
Rebound Anticipated For China Stock Market

Rebound Anticipated For China Stock Market

The China stock market on Wednesday snapped the three-day winning streak in which it had advanced almost 85 points or 2.6. The Shanghai Composite now sits just beneath the 3,365-point plateau although it may bounce higher again on Thursday.
RTTNews | hace 6h 5min
Higher Open Anticipated For Taiwan Stock Market

Higher Open Anticipated For Taiwan Stock Market

The Taiwan stock market has tracked higher in three straight sessions, improving almost 1,000 points or 4.3 percent in that span. The Taiwan Stock Exchange now rests just above the 23,250-point plateau and it may move to the upside again on Thursday.
RTTNews | hace 6h 35min
Singapore Stock Market May Add To Its Winnings

Singapore Stock Market May Add To Its Winnings

The Singapore stock market has tracked higher in five straight sessions, collecting more than 90 points or 2.4 percent along the way. The Straits Times Index now rests just beneath the 3,800-point plateau and it's tipped to open in the green again on Thursday.
RTTNews | hace 7h 5min