RMAT designation reinforces clinical significance of investigational biologic product TTAX02 used during in-utero fetal surgical repair of spina bifida
As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to treat this novel virus.
U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).
Vault will make thousands of saliva tests available nationwide with RUCDR Infinite Biologics
The U.S. Food and Drug Administration (FDA) announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics' total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.
Seattle's AVM Biotechnology announces clinical trial approval for AVM0703, an exciting new drug to treat terminal no-option Non-Hodgkins Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia.
Action Allows Perfusor® Space, Infusomat® Space, and Outlook® ES Pumps to be Used for Tracheal Delivery of Continuous Nebulized Medications into a Nebulizer
CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection.
The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
EC5026 is the first soluble epoxide hydrolase inhibitor developed to treat neuropathic pain
Breakthrough Therapy Designation and Submission based on positive Phase III JAVELIN Bladder 100 study results
The U.S. Food and Drug Administration approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.
Viracta intends to request an end-of-Phase 2 (EOP2) meeting later in 2020.
Polaryx Therapeutics, a biotech company developing patient-friendly, small molecule therapeutics for lysosomal storage disorders, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has gone live with an initial phase of its digital pathology solution at New York's Hospital for Special Surgery (HSS), the world's leading academic medical center focused on musculoskeletal health.
Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players
Luminex is now able to provide SARS-CoV-2 diagnostic tests for both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing facilities
Perrigo Company plc (NYSE: PRGO; TASE) announced that it was the first to receive approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA)
StrataGraft Skin Tissue Could be a Potential New Treatment Option for Deep Partial-Thickness Thermal Burns, if Approved
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the company's New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.