F2G LTD: F2G Receives US FDA Breakthrough Therapy Designation for Olorofim
In Phase 2b development for the treatment of life-threatening fungal infections
In Phase 2b development for the treatment of life-threatening fungal infections
Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Application is being reviewed under the FDA's Real-Time Oncology Review pilot program
TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands
Public health and safety is the highest priority at the U.S. Food and Drug Administration.
Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow
This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes
Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology.
Will be available in fall 2020, in time for the 2020-2021 flu season
Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
The future of imaging is here—and FDA cleared.
NMOSD is a rare disease where repeated relapses may result in visual impairment and motor disability in the course of disease progression
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability
Global recognition of the MADISON’s clinical value
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.