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.

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

Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved PERSERIS™, the first once-monthly subcutaneous ...


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 and Curb...


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 and Curb...


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 development of...


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 development of...


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 date ...


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 date ...


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

RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system. RD1 is an innovative...


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

RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system. RD1 is an innovative...


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, 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)

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


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

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


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

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIO™ (aripiprazole lauroxil)...


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

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIO™ (aripiprazole lauroxil)...


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 Denervation...


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 Denervation...


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 popularity ...