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

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...


15 Jun, 2018, 09:00 BST BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder

BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced...


14 Jun, 2018, 14:00 BST BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder

BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced...


14 Jun, 2018, 09:00 BST Geneva Company Announces U.S. Food and Drug Administration Clearance for Wearable Medical Device to Treat Drug Addiction

DyAnsys Europe SARL has announced that its parent company, DyAnsys Inc., has U.S. Food and Drug Administration clearance for an auricular...


12 Jun, 2018, 09:00 BST icotec AG Received FDA Clearance to Market BlackArmor® Carbon/PEEK Interbody Cages

The BlackArmor® Carbon/PEEK cervical and lumbar interbody cages are composed of icotec's innovative material, which is radiolucent and rapidly...


24 May, 2018, 16:00 BST AGC Biologics Cleared for Commercial Manufacture of Portola's FDA-Approved Andexxa®

Drug Substance produced in AGC Biologics' facility in Bothell, Washington AGC Biologics, a global leader in clinical and commercial...


23 May, 2018, 12:42 BST BERG Announces FDA Orphan-Drug Designation of BPM 31510 for the Treatment of Patients with Epidermolysis Bullosa

BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced that the...


22 May, 2018, 09:00 BST Bioprojet: Pitolisant Progresses Towards the U.S. Market

FAST TRACK AND BREAKTHROUGH DESIGNATIONS BY THE FDA AND FIRST U.S. NARCOLEPSY PATIENTS INCLUDED IN AN EXPANDED ACCESS PROGRAM Bioprojet is...


08 May, 2018, 14:02 BST First Cardiac Procedure Using the AcQMap® System by Acutus Medical® Successfully Performed in the United States

- New European/Canadian Clinical Study Initiated to Evaluate the AcQMap® System During an Atrial Fibrillation Retreatment Ablation Procedure -...


08 May, 2018, 08:00 BST FDA Grants Fast Track Designation to Debiopharm International's Debio 1347 for the Treatment of Patients With Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration

Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company,...


07 May, 2018, 12:00 BST Norgine Announces US FDA Approval for PLENVU® (NER1006) - 1 Litre PEG Based Bowel Cleansing Preparation for Colonoscopy

- US launch date: second half of 2018 - In Europe, PLENVU® is available through Norgine Norgine B.V. today announced that...


30 Apr, 2018, 14:00 BST Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Filing supported by data from MERIT-1 trial evaluating OPSUMIT in adults with inoperable CTEPH which showed significant improvements in pulmonary...