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| Arcutis Biotherapeutics, Inc.: FDA Accepts Supplemental New Drug Application for Arcutis' ZORYVE (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5 | Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children... ► Artikel lesen |
| Arcutis Biotherapeutics, Inc.: Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology | ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52 weeksOnce-daily ZORYVE foam 0.3% is approved... ► Artikel lesen |
| Arcutis Biotherapeutics, Inc.: Arcutis Outlines Strategy for Driving Sustainable Growth and Announces Third Quarter 2025 Financial Results | Q3 2025 net product revenue for ZORYVE® (roflumilast) was $99.2 million, a 122% increase compared to Q3 of 2024, and a 22% increase compared to Q2 of 2025 ZORYVE cream 0.05% received U.S. Food and... ► Artikel lesen |
| Disc Medicine Inc: Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business Update | Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025; Awarded the FDA Commissioner's National Priority Voucher... ► Artikel lesen |
| Disc Medicine Inc: Disc Medicine Provides Update on Hematology Portfolio and Outlines Near-Term Business Objectives and Anticipated Milestones | Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025, and subsequently was awarded the FDA Commissioner's National... ► Artikel lesen |
| Disc Medicine Inc: Disc Medicine Announces Receipt of FDA Commissioner's National Priority Voucher (CNPV) for Bitopertin in Erythropoietic Protoporphyria (EPP) | Disc is seeking accelerated approval of bitopertin for patients aged 12 years and older with EPPThe CNPV program is designed to reduce the drug application review process to 1-2 months WATERTOWN,... ► Artikel lesen |
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