Latest News
FDA: Awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
The U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years.
FDA: Reaffirms Commitment to Safety, Security of its Public Health Laboratories
The U.S. Food and Drug Administration’s mission to protect and promote public health by ensuring the safety of the nation’s food supply, as well as the safety and efficacy of medical products, has always relied on a rigorous analysis of the scientific data available and a strong commitment to safety.
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
CLYRA MEDICAL TECHNOLOGIES: Clyraguard, A Hospital-Grade, FDA-Registered Disinfectant For Face Masks And Coverings, Is Now Available To Consumers
Tested at Galveston National Laboratory, Clyraguard has shown complete inactivation of SARS-CoV-2 (COVID-19), providing an additional safeguard against airborne viruses
BIOSENSE WEBSTER: Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation
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: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for AGLE-102 for Patients with Dystrophic Epidermolysis Bullosa
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: Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
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: FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa
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: Treatment for Alexander disease receives orphan drug designation from U.S. FDA
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.
CSL BEHRING: U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
HAEGARDA is the first and only subcutaneous prophylactic HAE treatment approved for children 6 years of age and older
FDA: Approves Drug Combination for Treating Mesothelioma
First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibers
FDA: Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
Approval is for hypereosinophilic syndrome, which occurs when there is a high number of a type of white blood cells
FDA: Takes Actions to Help Lower U.S. Prescription Drug Prices
Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets
IAOMT: FDA Issues Mercury Amalgam Filling Warning, Group Calls For Even More Protection
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: FDA Grants Spirovant Sciences Orphan Drug and Rare Pediatric Disease Designations for SPIRO-2101 for Treatment of Cystic Fibrosis
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: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for IVT-8086 for the Treatment of Osteosarcoma
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: Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer
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.
FDA: Authorizes First Point-of-Care Antibody Test for COVID-19
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: Submits Pre-Market Approval Supplement to FDA to Enable ThinPrep® Pap Test™ PreservCyt® Solution to be Used with the BD Onclarity™ HPV Assay
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.