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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11 Feb, 2020, 07:00 GMT FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for...


21 Jan, 2020, 10:00 GMT OBI Pharma Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

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


14 Jan, 2020, 07:00 GMT Phagenesis Receives FDA Breakthrough Device Designation for Its Phagenyx® System to Accelerate Removal of the Breathing Tube by Treating Neurogenic Dysphagia

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device...


09 Jan, 2020, 12:30 GMT CPDC's Radiopharmaceutical Manufacturing Facility Receives Clearance from FDA

HAMILTON, Ontario, Jan. 9, 2020 /CNW/ - The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production ...


26 Dec, 2019, 10:00 GMT OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

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 Dec, 2019, 17:13 GMT TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology

LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital...


05 Dec, 2019, 11:00 GMT MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement TORONTO, Dec. 5, 2019 /CNW/ - MolecuLight...


04 Dec, 2019, 11:22 GMT FDA Grants Orphan Drug Designation to APR Applied Pharma Research's Investigational Drug for the Treatment of Epidermolysis Bullosa

APR Applied Pharma Research sa ("APR"), the Swiss pharma company focused in niche and rare therapeutic areas, announces that the US Food and Drug...