FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Latest

06:00 ET FDA Authorizes FRESCA Medical To Market New Positive Airway Pressure Delivery System To Treat Sleep Apnea

FRESCA Medical, Inc., a privately held sleep solutions and connected health company, announced today that the U.S. Food and Drug Administration...


Jun 22, 2018, 15:29 ET TVA Medical Receives FDA De Novo Marketing Authorization For everlinQ® endoAVF System

TVA Medical, Inc. today announced it has received U.S. Food and Drug Administration (FDA) De Novo marketing authorization of the everlinQ® endoAVF...


Jun 22, 2018, 13:24 ET FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and...


Jun 22, 2018, 09:00 ET Processa Pharmaceuticals Receives Orphan Designation Status For PCS499 In Necrobiosis Lipoidica From The Food And Drug Administration (FDA)

Processa Pharmaceuticals, Inc. (OTC: PCSA) a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of...


Jun 21, 2018, 17:32 ET FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device...


Jun 21, 2018, 15:40 ET FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and...


Jun 21, 2018, 15:14 ET FDA Approves World's First Long-Term Implantable Continuous Glucose Monitoring System for Marketing in United States

Senseonics Holdings, Inc. (NYSE American: SENS) today announced the U.S. Food and Drug Administration has approved its Premarket Approval (PMA)...


Jun 21, 2018, 08:25 ET Oramed Initiates Food Effect Study for Its Oral Insulin Capsule ORMD-0801

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of...


Jun 20, 2018, 17:09 ET Tenon Medical, Inc. Receives FDA Clearance For Sacroiliac Joint Fusion System

Tenon Medical, Inc., a manufacturer of minimally invasive instruments and implants for sacroiliac joint fusion surgery, today announced that it has...


Jun 20, 2018, 10:28 ET FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection

Acurx Pharmaceuticals, LLC ("Acurx" or the "Company"), a privately held clinical stage biopharmaceutical company focused on developing new...


Jun 20, 2018, 10:20 ET AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial

AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration (FDA)...


Jun 19, 2018, 16:02 ET Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of new evidence that Cosentyx® (secukinumab)...


Jun 19, 2018, 08:25 ET Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of...


Jun 19, 2018, 08:00 ET Spectra Medical Devices, Inc. Obtains FDA Approval to Market a Single Use 1% Lidocaine Ampule Where the Increased Need is in High Demand

Spectra Medical Devices, Inc., a Massachusetts based leading medical device company, is making a major impact and servicing the high demand...


Jun 18, 2018, 12:36 ET The US FDA Approves First Supplemental Abbreviated New Drug Application (sANDA) for Glenmark Pharmaceuticals' Manufacturing Facility in Monroe, North Carolina

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food & Drug Administration provided its first...


Jun 18, 2018, 09:00 ET Arcuro Medical Receives FDA Regulatory Clearance

Arcuro Medical Ltd. ("Arcuro"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it...


Jun 18, 2018, 09:00 ET Migraine Abortion Phase 3 Trial (TEAM study) with Cefaly® ACUTE Medical Device is Progressing Quickly

The Cefaly® ACUTE medical device, recently cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine, is the...


Jun 18, 2018, 08:27 ET FDA Approves the Next Generation of Customized LASIK Treatment with iDESIGN Refractive Studio

Johnson & Johnson Vision announced today the U.S. Food and Drug Administration (FDA) approval of the iDESIGN Refractive Studio, making it the...


Jun 18, 2018, 08:00 ET DreaMed Diabetes Granted FDA Authorization to Market Advisor Pro, Offering Personalized Optimization of Insulin Pump Therapy

DreaMed Diabetes, developer of personalized diabetes management solutions, announced today that the U.S Food and Drug Administration (FDA) has...


Jun 18, 2018, 02:45 ET Continued Discussions With FDA on Proposed Remetinostat Phase III Design Results in Delay in Planned Start of Study

Medivir AB (Nasdaq Stockholm: MVIR) today announced that the Board of Directors have decided to continue the discussions with the US Food and Drug...


Jun 15, 2018, 12:00 ET Dr. Reddy's Laboratories announces USFDA final approval and launch of Buprenorphine and Naloxone Sublingual Film in the U.S. Market

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has received final approval from the U.S. Food and...


Jun 15, 2018, 10:11 ET Indivior Responds to Generic SUBOXONE® Approvals and Dr. Reddy's Launch "At-Risk"

Indivior PLC (LON: INDV) ("Indivior" or the "Company") today announced that it is aware that, on 14 June 2018, the US FDA approved generic versions...


Jun 15, 2018, 04:00 ET BlueWind Medical erhält FDA-Zulassung für Schlüsselstudie des implantierbaren Tibialisnerv-Neuromodulators RENOVA iStim™ für die Behandlung der überaktiven Blase

BlueWind Medical, der Entwickler einer drahtlosen Miniatur-Neurostimulationsplattform für die Behandlung mehrerer klinischer Indikationen, gab...


Jun 15, 2018, 04:00 ET BlueWind Medical reçoit l'approbation de la FDA pour la conception de l'étude pivot portant sur RENOVA iStim™, un neuromodulateur implantable dans le nerf tibial dans le cadre de l'hyperactivité vésicale

BlueWind Medical, entreprise qui développe une plateforme de neurostimulation miniature sans fil, destinée au traitement de multiples indications...


Jun 15, 2018, 04:00 ET BlueWind Medical ontvangt goedkeuring van de FDA voor essentieel proefontwerp van RENOVA iStim™ implanteerbare scheenbeenzenuw-neuromodulator voor een overactieve blaas

BlueWind Medical, een ontwikkelaar van een miniatuur draadloos neurostimulatie-platform, voor de behandeling van verschillende klinische...


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