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The U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.
World's first single-use two channel ECG and heart rate biosensor provides 72-hour patient monitoring with remote data access in ambulatory, hospital and home settings
Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability
KeraNetics Inc. announces today that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has been cleared by the US Food and Drug Administration for indications of radiation dermatitis.
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the development and advancement of immunology based therapies for prevalent inflammatory conditions, today announced the publication "Insights into pediatric multi-system inflammatory syndrome and COVID-19."
TCI GENE, a subsidiary of TCI Co., Ltd. (Ticker: 8436) that produces the MOHW-certified QVS-96 system delivered to Kunyang Laboratory, CDC, Taiwan, has been registered with U.S. FDA and qualified to sell the fully automated detection integration system in the U.S. With the high influence of the US FDA in the world, it is believed that FDA in many countries will refer to its standard for the certification of the system, and it is expected that the system will be installed in major airports around the world to support epidemic prevention and help restore high traffic for economic recovery.
The U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps).
Application Based on First Contemporary Outcomes Study Focused Exclusively on Chronic Heart Failure Patient Population Following a Worsening Event
Pharmaceutical innovator Galt Pharmaceuticals announced a new drug approval to offer a non-opioid, non-controlled, non-addictive alternative for healthcare providers to manage patients suffering from pain.
Pataday® Once Daily Relief Extra Strength (olopatadine 0.7%) is the first and only eye allergy itch drop offering a full 24 hours of relief without a prescription in the U.S.1
Phase 1 clinical trial evaluating the off-the-shelf anti-BCMA CAR T candidate CYAD-211 for the treatment of relapsed/refractory multiple myeloma (r/r MM) expected to begin by year-end 2020
Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases
Fast Track Designation Highlights the Urgent Need for New Treatment Options
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced it received approval from the U.S. Food and Drug Administration (FDA) for the KONECT RESILIA aortic valved conduit (AVC), the first ready-to-implant solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient's aortic valve, aortic root and the ascending aorta.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that the FDA provided positive feedback during the company's End of Phase 2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801). Based on the FDA's feedback, Oramed intends to initiate two Phase 3 clinical trials following FDA review of those Phase 3 protocols, and nonclinical documents.
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM).
If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition
Designed to enhance bone growth and help achieve fusion in surgeries involving the skeletal system
BRILINTA in combination with aspirin could be the first FDA-approved dual antiplatelet therapy to reduce the rate of stroke in these high-risk patients
Portfolio Expansion Ensures Dogs and Puppies 8 Weeks of Age and Older Receive Early, Broad-Spectrum Protection Against Fleas and Ticks