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 FDA Approval

14 Aug, 2018, 13:42 BST FDA Approvals for Cardiac Electrophysiology Products Bright Spot in Healthcare Industry

MarketNewsUpdates.com News Commentary The rising prevalence of cardiac conditions such as flutter, atrial fibrillation and arrhythmia has driven...


08 Aug, 2018, 17:38 BST Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

- Poteligeo has been approved for the treatment of the two most common types of Cutaneous T-cell lymphoma (CTCL) in previously...


01 Aug, 2018, 13:00 BST FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML

- Quizartinib has received FDA Breakthrough Therapy designation in patients with relapsed/refractory FLT3-ITD AML, a very aggressive form of the...


30 Jul, 2018, 18:00 BST Sekisui Diagnostics Receives FDA Clearance for SEKURE® HbA1c Assay

Sekisui Diagnostics announces the FDA clearance of their SEKURE® HbA1c assay. The assay has been cleared to be used as an aid in the diagnosis of...


28 Jul, 2018, 01:06 BST FDA Approves PERSERIS™ (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

PERSERIS is the first once-monthly subcutaneous risperidone-containing long-acting injectable Indivior PLC (LON: INDV) today announced that...


25 Jul, 2018, 14:00 BST A Big Win for Digital Health: U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Testing - Healthy.io’s Dip.io Urinalysis

Approval Helps Healthy.io Usher in Era of Medical Selfie, Leveraging Embedded Smartphone Cameras to Improve Patient Adherence and Outcomes...


18 Jul, 2018, 09:00 BST Asceneuron's Tau Modifier ASN120290 Receives Orphan Drug Designation for Progressive Supranuclear Palsy From the FDA

Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles Asceneuron SA, an emerging leader in the...


16 Jul, 2018, 07:32 BST Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder

Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal...


10 Jul, 2018, 13:00 BST RedDress Receives FDA 510(k) Clearance for RD1 System

Innovative Device for Wound Management RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k)...


10 Jul, 2018, 11:49 BST BioArctic Receives Regulatory Approval in Finland for a Clinical Study in Patients With Complete Spinal Cord Injury

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by Fimea, the Finnish Medicines Agency, and...


09 Jul, 2018, 14:00 BST Oculocare's Alleye® Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD

Oculocare medical Inc., a Swiss technology company, announces today the FDA 510(k) clearance of Alleye®, a mobile medical software application...


09 Jul, 2018, 10:00 BST OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)

First Orphan Drug Designation for OBI-3424, a novel first-in-class targeted therapy for solid tumors that express aldo-keto reductase 1c3 (AKR1C3)...


02 Jul, 2018, 12:01 BST FDA Approves ARISTADA INITIO™ for the Initiation of ARISTADA® for Schizophrenia

— Novel Regimen Enables Physicians to Fully Dose Up to Two Months of ARISTADA Treatment on Day One — Alkermes plc (Nasdaq: ALKS) today...


02 Jul, 2018, 06:10 BST ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise® Ultrasound Denervation System For Treatment Of Hypertension

ReCor Medical announced today that the US Food & Drug Administration approved the Company's new pivotal study of the Paradise Ultrasound...


27 Jun, 2018, 21:15 BST Jazz Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review its...


27 Jun, 2018, 13:58 BST Why FDA's Approval of First Cannabidiol (CBD) Treatment is a Major Milestone for CBD Industry

FN Media Group News Commentary There's no doubt that cannabidiol or CBD has seen a remarkable increase in popularity across the globe. The...


15 Jun, 2018, 09:00 BST BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder

BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced...


14 Jun, 2018, 14:00 BST BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder

BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced...


14 Jun, 2018, 09:00 BST Geneva Company Announces U.S. Food and Drug Administration Clearance for Wearable Medical Device to Treat Drug Addiction

DyAnsys Europe SARL has announced that its parent company, DyAnsys Inc., has U.S. Food and Drug Administration clearance for an auricular...


12 Jun, 2018, 09:00 BST icotec AG Received FDA Clearance to Market BlackArmor® Carbon/PEEK Interbody Cages

The BlackArmor® Carbon/PEEK cervical and lumbar interbody cages are composed of icotec's innovative material, which is radiolucent and rapidly...


24 May, 2018, 16:00 BST AGC Biologics Cleared for Commercial Manufacture of Portola's FDA-Approved Andexxa®

Drug Substance produced in AGC Biologics' facility in Bothell, Washington AGC Biologics, a global leader in clinical and commercial...


23 May, 2018, 12:42 BST BERG Announces FDA Orphan-Drug Designation of BPM 31510 for the Treatment of Patients with Epidermolysis Bullosa

BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced that the...


22 May, 2018, 09:00 BST Bioprojet: Pitolisant Progresses Towards the U.S. Market

FAST TRACK AND BREAKTHROUGH DESIGNATIONS BY THE FDA AND FIRST U.S. NARCOLEPSY PATIENTS INCLUDED IN AN EXPANDED ACCESS PROGRAM Bioprojet is...


08 May, 2018, 14:02 BST First Cardiac Procedure Using the AcQMap® System by Acutus Medical® Successfully Performed in the United States

- New European/Canadian Clinical Study Initiated to Evaluate the AcQMap® System During an Atrial Fibrillation Retreatment Ablation Procedure -...


08 May, 2018, 08:00 BST FDA Grants Fast Track Designation to Debiopharm International's Debio 1347 for the Treatment of Patients With Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration

Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company,...


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