Tag Archive for: FDA

Shionogi Co., Ltd. and F2G Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia

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Shionogi to conduct clinical trials, subsequent registration, and commercialization of olorofim for invasive aspergillosis (IA) in Europe and Asia F2G to receive upfront payment of $100m and share development costs F2G will also be eligible for additional regulatory and commercial milestones of up to $380m, as well as double-digit royalties on net sales OSAKA, Japan, […]

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Verona Pharma Completes Enrollment in ENHANCE-1 48-week Subset

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ENHANCE-2 Screening Complete with Full Enrollment Expected in January 2022 ENHANCE Phase 3 Program on Track to Report Top-line Data in 2022 LONDON and RALEIGH, N.C., Jan. 05, 2022 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces enrollment completed in the […]

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FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy

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TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g1 TARPEYO (developed under the project name NEFECON) is the first and only FDA- approved treatment that was specifically designed for […]

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