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

15 Oct, 2018, 16:00 BST CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System

CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, is delighted to announce FDA...


12 Oct, 2018, 15:05 BST FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing

Test Offers Shortest Time to Reportable Results For US Hospitals, Reference Labs and Blood Centers - Efficient system analyzes 37 antigens of 10...


11 Oct, 2018, 16:22 BST Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation

Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial...


03 Oct, 2018, 13:00 BST PARI Pharma's eFlow® Technology device, LAMIRA™, approved as the only nebulizer system to deliver Insmed's ARIKAYCE® (amikacin liposome inhalation suspension)

- ARIKAYCE is the First and Only Therapy Specifically Indicated for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease in Adult...


19 Sep, 2018, 10:00 BST OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)

Second Orphan Drug Designation for OBI-3424, a novel first-in-class targeted therapy for solid and liquid tumors that express aldo-keto reductase...


19 Sep, 2018, 06:00 BST Pharming Receives Complete Response Letter from FDA

Additional clinical trial data for prophylaxis of HAE requested Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM)...


06 Sep, 2018, 07:57 BST NeuroVive Receives Positive FDA Feedback on its NeuroSTAT TBI Development Plan

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced positive U.S. Food and Drug Administration (FDA) feedback on its...


22 Aug, 2018, 14:27 BST COMPASS Pathways Receives FDA Approval for Psilocybin Therapy Clinical Trial for Treatment-resistant Depression

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received...


22 Aug, 2018, 13:00 BST MagVenture, Inc: FDA Clears 3-Minute, Non-Pharmaceutical Depression Treatment

For people suffering from severe depression, the road to remission just became a lot shorter: The treatment is known as Transcranial Magnetic...


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...


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