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

10 Oct, 2017, 15:24 BST Respicardia's remedē® System Receives FDA Approval

Breakthrough Treatment of Moderate to Severe Central Sleep Apnea in Adult Patients Now Available Respicardia, Inc., a private medical...


10 Oct, 2017, 13:30 BST Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare...


06 Oct, 2017, 13:07 BST Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device

The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food...


04 Oct, 2017, 18:00 BST Transfer of Regulatory Jurisdiction for Oxitec's Self-limiting Friendly™ Aedes in the United States

FDA issues final Guidance for Industry, transferring regulatory authority to EPA Following new Guidance issued by the U.S. Food and Drug...


04 Oct, 2017, 09:00 BST CALCIVIS Closes Equity Funding to Advance its CALCIVIS Imaging System to Market

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has...


27 Sep, 2017, 23:41 BST No More Routine Finger Sticks(1) for Americans with Diabetes: Abbott′s FreeStyle® Libre Approved in the U.S.

- REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION -...


18 Sep, 2017, 09:17 BST Camurus Announces That FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder

The FDA has assigned a PDUFA target date of January 19, 2018 Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration...


11 Sep, 2017, 06:00 BST Pharming Announces Conclusion of FDA End of Phase 2 Interactions on RUCONEST® for Prophylaxis of HAE

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2...


31 Aug, 2017, 15:39 BST U.S. FDA Approves Chemo Group's Benznidazole to Treat Children with Chagas Disease

On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the...


25 Aug, 2017, 07:30 BST US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome

Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced that U.S. Food and Drug...


22 Aug, 2017, 02:00 BST Vascular Dynamics, a Part of the Rainbow Medical Investment Cluster, Received FDA Approval to Begin Conclusive and Pivotal Trial Experimentation for Their Flagship Product Designed to Treat Chronic Hypertension

- The experiment will examine the effectiveness of the MobiusHD implant in the reduction of blood pressure among chronic patients for...


09 Aug, 2017, 16:09 BST InDex Pharmaceuticals Receives Orphan-drug Designation for Pediatric Ulcerative Colitis in the US

InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the...


08 Aug, 2017, 13:08 BST Ferring Pharmaceuticals: The Scottish Medicines Consortium Approves Use of NOQDIRNA® (oral lyophilisate desmopressin), the First Licensed Treatment for Nocturia due to Idiopathic Nocturnal Polyuria in Adults

- The Scottish Medicines Consortium (SMC) has announced today a positive decision for the use of NOQDIRNA®.[1] - NOQDIRNA® is...


03 Aug, 2017, 15:15 BST Jazz Pharmaceuticals Announces Webcast for Vyxeos Investor Update

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast on Monday, August 7, 2017 at 4:30 p.m. EDT/9:30 p.m....


03 Aug, 2017, 10:00 BST Arjuna Natural BCM-95® Curcumin Confirmed by FDA

BCM-95® Turmeric Extract Granted a 'No Questions' Letter from the FDA Arjuna Naturals Extracts Ltd.'s BCM-95®, a high-potency...


28 Jul, 2017, 14:00 BST Top Companies Receiving Orphan Drug Designation in 2017

Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease...


27 Jul, 2017, 08:00 BST AMO Pharma Receives FDA Orphan Drug Designation for AMO-02 for Treatment of Congenital Myotonic Dystrophy

AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment...


26 Jul, 2017, 13:05 BST Sequoia Sciences Receives FDA Fast Track Designation for Vaccine for Urinary Tract Infections Caused by Multidrug-Resistant Bacteria

Non-Antibiotic Treatment Approach May Reduce the Development of Antibiotic Resistance and Promote Antibiotic Stewardship Sequoia Sciences...


25 Jul, 2017, 14:00 BST Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial

"BETonMACE Phase 3 Trial with apabetalone to expand to include the United States" Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)...


25 Jul, 2017, 05:00 BST U.S. FDA Determines Celliant® Responsive Textile Products Meet Criteria as Medical Devices and General Wellness Products

- Hologenix, LLC's technology is first of its kind to secure joint FDA designations - Celliant-engineered products clinically proven to promote...