Tag Archive for: FDA

Nordic Bioscience receives Letter of Support from the FDA for the PRO-C3 biomarker in tumor fibrosis

Nordic Bioscience receives Letter of Support from the U.S. Food and Drug Administration (FDA) for further study of the PRO-C3 biomarker assay in tumor fibrosis studies Paves way for further testing of the PRO-C3 biomarker assay, which identifies patients with hard to treat ‘fibrotic’ tumors, in further clinical trials US FDA recognizes need for a […]

Futura’s Fast-Acting Topical Gel for the Treatment of Erectile Dysfunction Granted Marketing Authorisation by the US FDA for Over the Counter Sale

Futura Medical plc (AIM: FUM) (“Futura” or the “Company”), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology currently focused on sexual health, today announces that the US Food and Drug Administration (“FDA”) has granted over the counter sale (“OTC”) Marketing Authorisation for MED3000, the Company’s breakthrough, topical gel formulation for the treatment […]

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

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, […]

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

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 […]

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

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 […]