BECKMAN COULTER: SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization
Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA
Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA
Tested at Galveston National Laboratory, Clyraguard has shown complete inactivation of SARS-CoV-2 (COVID-19), providing an additional safeguard against airborne viruses
The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients*
Aegle Therapeutics Corporation, a first-in-class biotechnology company committed to delivering cell-free therapy to patients affected by severe dermatological conditions, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation to AGLE-102™ for the treatment of dystrophic epidermolysis bullosa (DEB), a skin blistering disorder.
CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that the United States (US) Food and Drug Administration (FDA) has granted orphan drug designation to one of CARsgen's first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma.
Aegle Therapeutics Corporation today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AGLE-102™ for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ION373 for the treatment of people with Alexander disease, a severe, progressive and debilitating rare neurodegenerative disease that can result in death.
HAEGARDA is the first and only subcutaneous prophylactic HAE treatment approved for children 6 years of age and older
First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibers
Approval is for hypereosinophilic syndrome, which occurs when there is a high number of a type of white blood cells
Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets
The International Academy of Oral Medicine and Toxicology (IAOMT) is commending the Food and Drug Administration (FDA) for its statement yesterday that warns high-risk groups about the potential for adverse health outcomes from dental amalgam mercury fillings.
Spirovant Sciences, a gene therapy company developing treatments and cures for genetic lung diseases including cystic fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designations to its lead product candidate, SPIRO-2101, for the treatment of cystic fibrosis.
Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, today announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.
U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the use of the ThinPrep® Pap Test™ PreservCyt® Solution vial as an approved sample type for its BD Onclarity™ HPV Assay.
Boxed Warning to Be Updated to Include Abuse, Addiction and Other Serious Risks
U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).
The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative.