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Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has filed a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast) 0.05% with the US Food and Drug Administration (FDA). The application seeks approval for the topical use of Zoryve in children…
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Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing has been made in China for its drug candidate SHR0302, intended to treat active ankylosing spondylitis in patients who have responded poorly to non-steroidal anti-inflammatory drugs (NSAIDs). Phase II/III Study Results Support FilingThe filing is…
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Huadong Medicine Secures Exclusive Rights to Arcutis’ Daxas in Greater China and South-East Asia
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Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant licensing agreement with Arcutis (NASDAQ: ARQT), securing exclusive rights to develop, file for regulatory approval, manufacture, and commercialize Arcutis’ Daxas (roflumilast, including cream ZORYVE and foam agent ARQ-154) external preparations in Greater China and South-East Asia. Financial Terms and CommitmentsUnder…
