FDA: Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer
U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).
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VAULT HEALTH: Launches First-of-its-Kind Saliva-based FDA EUA Approved Test for COVID-19
Vault will make thousands of saliva tests available nationwide with RUCDR Infinite Biologics
ORTHO CLINICAL DIAGNOSTICS: Ortho's Total Antibody Test for COVID-19 Receives Emergency Use Authorization from FDA
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.
AVM BIOTECHNOLOGY: FDA Approval for Clinical Trials for Promising New Cancer Treatment
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.
B. BRAUN: Receives FDA Emergency Use Authorization for Use of Infusion Pumps with Nebulizers to Treat COVID-19 Patients
Action Allows Perfusor® Space, Infusomat® Space, and Outlook® ES Pumps to be Used for Tracheal Delivery of Continuous Nebulized Medications into a Nebulizer
CYTOSORBENTS: U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection
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.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19
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.
EICOSIS: EC5026 Granted Fast Track Designation by FDA for Neuropathic Pain
EC5026 is the first soluble epoxide hydrolase inhibitor developed to treat neuropathic pain
EMD SERONO AND PFIZER: Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO® for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Breakthrough Therapy Designation and Submission based on positive Phase III JAVELIN Bladder 100 study results
FDA: Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm
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: Receives Welcome FDA Guidance at Type C Meeting for the Treatment of EBV-Associated Lymphomas
Viracta intends to request an end-of-Phase 2 (EOP2) meeting later in 2020.
POLARYX THERAPEUTICS: Receives IND Approval From the FDA to Study PLX-200 Treatment for Patients With Juvenile Neuronal Ceroid Lipofuscinosis
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.
SECTRA, INC.: Sectra and Hospital for Special Surgery Collaborate to Integrate FDA Approved Digital Pathology Imaging Solution
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.
NITILOOP: Nitiloop's NovaCross Earns FDA Clearance for Treating Chronic Total Occlusion (CTO) Prior to PTCA or Stent Intervention
Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players
LUMINEX: Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease
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: Announces FDA Approval for the Store Brand Equivalent of Voltaren® Arthritis Pain
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)
MALLINCKRODT: Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration
StrataGraft Skin Tissue Could be a Potential New Treatment Option for Deep Partial-Thickness Thermal Burns, if Approved
JAZZ PHARMACEUTICALS: Announces FDA Acceptance of New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
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.
VERO BIOTECH: Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL® DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
Treatment informs FDA approval for emergency expanded access use for GENOSYL® inhaled nitric oxide
AMPIO PHARMACEUTICALS, INC.: Ampio is Preparing an Expanded Access FDA protocol to Study Nebulized Ampion as a Treatment for Moderate to Severe Acute Respiratory Distress Syndrome Associated with COVID-19
Ampio Pharmaceuticals, Inc. issued the following announcement on March 24.Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions for which limited treatment options exist, announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory Distress Syndrome ("ARDS"), an immediately life-threatening condition.Ampio's Scientific Advisory Board ("SAB") members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication.