The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds).
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.
A new paper in AACC's Clinical Chemistry journal outlines recommendations for labs
NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.
Innovative therapy candidate uses next generation mesenchymal stem cells (MSCs) derived from a master cell bank of induced pluripotent stem cells (iPSCs)
ONGENTYS, the First and Only Approved Once-Daily COMT Inhibitor, Decreases "Off" Time and Increases "On" Time Without Troublesome Dyskinesia When Added to Levodopa/Carbidopa in Patients with Parkinson's Disease
ALung Technologies, Inc. issued the following announcement on April 24.ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company Emergency Use Authorization (EUA) designation to the Hemolung® Respiratory Assist System (RAS) for the treatment of Coronavirus Disease 2019 (COVID-19) patients.
AmideBio, LLC, a privately held biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) Office of Orphan Products Development granted an orphan drug designation to AmideBio's glucagon analog (ABG-023) for the treatment of congenital hyperinsulinism (CHI).
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
The U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body.
If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
Patients ages 70 years or younger who were new to CLL treatment lived longer without disease progression with the IMBRUVICA®-based regimen compared to patients treated with a chemoimmunotherapy regimen
Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma.
The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19.
CytoSorbents Corporation issued the following announcement on April 20.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 that the U.S.
Asia's first company to sponsor clinical trial of combination therapy of anti-cancer microbiome and anti-PD1/anti-PD-L1 drug
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019.
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.