KITE: U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus
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FDA: Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
Authorization is also second to allow testing of pooled samples
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FDA: Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL
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.
LIFESIGNALS: Wireless Medical Biosensor LP1250 receives FDA clearance
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
CHANNEL MEDSYSTEMS: Receives FDA Approval of its Latest Cerene® Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting
Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability
KERANETICS: Announces KeraStat® Cream product cleared by FDA for radiation dermatitis
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: Reports a Publication on the Potential Benefits of Ampion for Treatment of a New COVID-19 related Syndrome
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 BIO: TCI GENE, registered with US FDA, aims to support accurate testing in international airports
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.
FDA: Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
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).
MERCK: FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat
Application Based on First Contemporary Outcomes Study Focused Exclusively on Chronic Heart Failure Patient Population Following a Worsening Event
GALT: Opioid-free Pain Med Orphengesic Forte by Galt Pharmaceuticals Approved by FDA
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.
ALCON: Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength
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
CELYAD ONCOLOGY: Announces FDA Clearance of IND Application for CYAD-211, First shRNA-based, Non-Gene Edited Allogeneic CAR T Therapy
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
INFLAZOME: FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases
DENOVO BIOPHARMA LLC: FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)
Fast Track Designation Highlights the Urgent Need for New Treatment Options
EDWARDS LIFESCIENCES CORPORATION: Edwards' KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries
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: Reports Positive End of Phase 2 Meeting With the FDA for Oral Insulin
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: Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Waldenström Macroglobulinemia
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).
MALLINCKRODT: Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition
BAXTER: Announces U.S. FDA Clearance of Altapore Shape Bioactive Bone Graft for Use in Surgery
Designed to enhance bone growth and help achieve fusion in surgeries involving the skeletal system