The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
U.S. FDA: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.
FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc.
XCOPRI is approved for the treatment of partial-onset seizures in adult patients
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.
ABBVIE: Submits Supplemental New Drug Application to U.S. FDA For IMBRUVICA® (ibrutinib) in Combination with Rituximab for the Treatment of Previously Untreated, Younger Adults with Chronic Lymphocytic Leukemia
Application is being reviewed under the FDA's Real-Time Oncology Review pilot program
TRANSTHERA BIOSCIENCES: Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma
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.
EIP PHARMA: Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)
Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands
U.S. FDA: Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices
Public health and safety is the highest priority at the U.S. Food and Drug Administration.
3D SYSTEMS: Expands its Industry-Leading Portfolio of Dental Materials with Newly FDA-Cleared NextDent® Denture 3D+
Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow
WELLDOC, INC: Welldoc's Award-winning Digital Health Solution BlueStar Adds FDA-Clearance for Use in Type 1 Diabetes
This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes
U.S. FDA: Authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
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.
SANOFI: FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older
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.
SURMODICS: The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
HEARTVISTA: Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution
The future of imaging is here—and FDA cleared.
CHUGAI PHARMACEUTICAL: EMA and FDA Accept Marketing Applications for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
NMOSD is a rare disease where repeated relapses may result in visual impairment and motor disability in the course of disease progression
GENETECH: FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
IMPULSE DYNAMICS: Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
ALKERMES: Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability