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

09:45 ET Therapeutic Solutions International Identifies New Mechanism of Mesenchymal Stem Cell Treatment of Brain Injury

Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today filing of a patent application covering novel findings demonstrating...


08:00 ET Zappogen Product Approved For Use Against COVID-19

Zappogen, a distributor of comprehensive, hospital-grade disinfecting solutions that help prevent the spread of harmful viruses, bacteria, fungi,...


Oct 26, 2020, 16:01 ET Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VSJ-110 for Allergic Conjunctivitis

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational...


Oct 26, 2020, 10:00 ET Medtronic Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval...


Oct 26, 2020, 09:00 ET Dunlee's liquid metal bearing CT replacement tube for Revolution™ Evo and Optima™ 660 scanners receives FDA clearance

Dunlee, a leading manufacturer of imaging solution components, announced its DA200P40+LMB CT replacement tube has received FDA clearance, and...


Oct 26, 2020, 09:00 ET Nerivio® Receives Clearance of Expanded Indication to Cover Chronic Migraine Patients

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced...


Oct 26, 2020, 08:30 ET Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix® COVID-19 Test

Helix, the leading population genomics company, announced that it received an expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug...


Oct 26, 2020, 08:30 ET Aeglea BioTherapeutics Announces U.S. and EU Orphan Drug Designations for ACN00177 for the Treatment of Homocystinuria

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as...


Oct 26, 2020, 08:30 ET Truvian Sciences Announces Plans to Make Rapid Antibody Testing More Accessible with Easy Check COVID-19 IgM/IgG™ POC Antibody Test

Truvian Sciences ("Truvian"), a healthcare company at the intersection of diagnostics and consumer technology, today announced its submission of the...


Oct 26, 2020, 07:30 ET SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization TORONTO,...


Oct 23, 2020, 11:27 ET PAOG Announces CRO Agreement To Advance Respiratory Cannabis Treatment Through Regulatory Approval

PAO Group, Inc. (USOTC: PAOG) today announced executing a master services agreement with a clinical research organization in the U.S. to prepare PAOG ...


Oct 23, 2020, 08:15 ET GI Supply Gets FDA Clearance for its Submucosal Lifting Agent in a Second Size, a Pre-filled 10mL Syringe

GI Supply today announced the FDA clearance of EverLift™ Submucosal Lifting Agent in a 10mL syringe, a new device for the lift of polyps, adenomas,...


Oct 22, 2020, 17:10 ET FDA Approves First Treatment for COVID-19

Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age ...


Oct 22, 2020, 08:35 ET Embody, Inc. Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair

Embody, Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair,...


Oct 21, 2020, 09:00 ET Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and...


Oct 21, 2020, 08:17 ET FLEX Vessel Prep™ System Receives New Indication to Address In-Stent Restenosis

VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral...


Oct 21, 2020, 08:00 ET Scopio Labs Receives FDA Clearance for its AI-Powered Full Field Peripheral Blood Smear (Full Field PBS) Application

Scopio Labs, a leading provider of Full Field Morphology (FFM), announced today that it was granted FDA clearance to market and sell its X100 with...


Oct 21, 2020, 07:45 ET Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN™ CITRELOCK™ Tendon Interference Screw System

Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITRELOCK™...


Oct 21, 2020, 07:30 ET Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems

Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine...


Oct 20, 2020, 10:56 ET PAOG FDA Application Process For Respiratory Cannabis Drug Treatment Update Scheduled This Friday

PAO Group, Inc. (USOTC: PAOG) today announced the company plans to release a new key update this Friday, October 23, 2020, on its progress to advance ...


Oct 20, 2020, 09:00 ET Ezra Receives FDA Clearance For Prostate Cancer Artificial Intelligence

Ezra, the NY-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) premarket authorization for ...


Oct 20, 2020, 08:00 ET U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration...


Oct 20, 2020, 07:00 ET Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence

Ezra, the New York-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) clearance for its...


Oct 19, 2020, 09:00 ET Neurelis Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)

Neurelis, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead...


Oct 19, 2020, 08:00 ET FDA Approves New Container System for Peritoneal Dialysis Solutions

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that DELFLEX® peritoneal dialysis solutions in Biofine®, an...