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: 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.
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
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.
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).
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
MERCK ANIMAL HEALTH: Receives U.S. FDA Approval of BRAVECTO® (fluralaner) Monthly Chews
Portfolio Expansion Ensures Dogs and Puppies 8 Weeks of Age and Older Receive Early, Broad-Spectrum Protection Against Fleas and Ticks
ABBVIE: FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
Updated Label Now Includes Pediatric Patients with Lower Limb Spasticity Caused by Cerebral Palsy
FDA: Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
The U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
ENDO INTERNATIONAL: U.S. FDA Approves Qwo™ (collagenase clostridium histolyticum-aaes), the First Injectable Treatment for Cellulite
Endo International plc issued the following announcement on July 6.Endo International plc (NASDAQ: ENDP) today announced that it received U.S.
FDA: Approves New HIV Treatment for Patients With Limited Treatment Options
The U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
CAMARGO PHARMACEUTICAL SERVICES: Camargo client Chiasma receives FDA approval for first and only oral somatostatin analog for long-term maintenance treatment of acromegaly
Camargo Pharmaceutical Services issued the following announcement on July 2.Original source can be found here.
EMD SERONO: FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study