Cybersecurity issues lead to recall of some Medtronic insulin pumps
Medtronic MiniMed 508 and MiniMed Paradigm series insulin pumps are being recalled because of cybersecurity concerns, according to the Food and Drug Administration.
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BIOTRONIK: Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III
Device is 60% Smaller, Offers Simplified One-Step Injection Procedure and Sets New Standard for Signal Quality
FDA panel: more research needed on potentially negative effects associated with paclitaxel-coated device treatment
While the long-term effects of treatment with paclitaxel-coated devices in the peripherals are still unclear, the U.S. Food and Drug Administration could not rule out an association with adverse effects, even at very low drug concentrations.
Daiichi Sankyo issues update on new cancer drug
Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.
Electronic skin patch companies grapple with changing reimbursement schemes, report says
Ever-changing reimbursement schemes are forcing firms involved in electronic skin patches to lobby and adapt or leave the sector altogether, a research report surveying the product category said.
MERCK: FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option.
CONTIPI MEDICAL LTD: Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women
This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder).
AZURITY PHARMACEUTICALS: FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older
Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.
FDA Update: June medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
OMEROS CORPORATION: Announces Agreement with FDA on Primary Endpoint for Narsoplimab BLA in Stem Cell Transplant-Associated TMA
All Criteria for the Response-Based Endpoint Now Finalized
SYNDAX PHARMACEUTICALS: Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias
SNDX-5613 is a potent, highly selective, oral inhibitor of the interaction of Menin with the Mixed Lineage Leukemia (MLL) protein
DISCGENICS, INC.: First Utahns treated in nationwide FDA-allowed clinical study of locally developed cell therapy for chronic low back pain
DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).
LA ROCHE-POSAY: Changes The Face Of Acne With Latest FDA Approved Acne Ingredient And Premieres Artificial Intelligence-Based Skin Analysis
La Roche-Posay Launches Effaclar Adapalene Gel 0.1% Acne Treatment and My Skin Track PoreScan
ABBOTT: Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply
Alinity™ s System will screen the U.S. blood and plasma supply faster and more efficiently while maintaining highest levels of accuracy
SENSORION: Receives FDA IND Approval for Arazasetron (SENS-401)
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
BAYER: FDA approves Bayer's Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease
Coronary artery disease (CAD) is an important public health issue-- a disease that affects 16.5 million Americans
TEVA PHARMACEUTICAL INDUSTRIES LTD: Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder
The First Digital Maintenance Asthma Inhaler Therapy with Integrated Sensors Joins Teva’s Digital Rescue Inhaler Therapy to Provide Patients with Technology to Track Treatment Use
ASTELLAS PHARMA INC.: Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology
Dravet Syndrome drug submitted for investigation
An investigational new drug application and fast track designation request for EPX-100, a treatment for Dravet Syndrome, were submitted to the Food and Drug Administration.
Treatment approved for rhinosinusitis with nasal polyps
Dupixent, an injectable medication, was approved by the Food and Drug Administration for the treatment of chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity) with nasal polyps (growths on the inner lining of the sinuses).