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

Oct 30, 2020, 10:44 ET Breakthrough for Syntellix - MAGNEZIX implant has been granted designation as a "Breakthrough Device" by the U.S. FDA

The U.S. Food & Drug Administration (FDA), Silver Spring / Maryland, has granted Syntellix's MAGNEZIX® CS 3.2 device and proposed indication for use...


Oct 29, 2020, 12:45 ET Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas® EGFR Mutation...


Oct 29, 2020, 10:14 ET PAOG Adds Nutraceutical Pathway To Pharmaceutical Cannabis Strategy

PAO Group, Inc. (USOTC: PAOG) today announced adding a nutraceutical development pathway to its existing pharmaceutical cannabis drug development...


Oct 29, 2020, 09:30 ET DiA Granted FDA Clearance for its Cardiac Ultrasound AI Auto Views Selection

DiA Imaging Analysis announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the commercial use of ...


Oct 29, 2020, 09:10 ET OncoSec Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19

OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced that the U.S. Food and Drug Administration (FDA) has approved ...


Oct 29, 2020, 07:00 ET Medtronic Expands ENT Portfolio with FDA Clearance of NIM Vital™ Next Generation Intraoperative Nerve Monitoring System and Acquisiton of Ai Biomed Corp.

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k)...


Oct 29, 2020, 05:45 ET Embody, Inc. Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair

Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early-stage healthcare companies with innovative...


Oct 28, 2020, 08:43 ET Cognita Labs Gets FDA Clearance for PulmoScan to Make Lung Testing Simple and Widely Accessible

Cognita Labs, a leading respiratory technologies company, today announced that the U.S. Food and Drug Administration (FDA) has issued clearance for...


Oct 28, 2020, 08:00 ET Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent

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


Oct 28, 2020, 06:30 ET Agena Bioscience Granted EUA for High-Throughput, Low-Cost SARS-CoV-2 Panel

Agena Bioscience®, a global provider of low-cost and high-throughput molecular testing solutions, today announced that its MassARRAY® SARS-CoV-2...


Oct 27, 2020, 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...


Oct 27, 2020, 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 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, 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, 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...