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

RTTNews | 894 dias atrás
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.

Marcadores : AMYT
read more
Japanese Market Significantly Higher

Japanese Market Significantly Higher

Adding to the gains in the previous three sessions, the Japanese market is significantly higher on Thursday, following the broadly positive cues from Wall Street overnight. The Nikkei 225 is moving well above the 38,500 level, with gains across most sectors led by index heavyweights, exporters and technology stocks, partially offset by weakness in automakers.
RTTNews | 5h 22min atrás
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 | 6h 9min atrás
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 | 6h 12min atrás
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 | 6h 24min atrás
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 | 6h 39min atrás