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

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...


20 Jul, 2017, 08:00 BST LEO Pharma Receives Marketing Authorisation for Kyntheum® (Brodalumab), a New Biologic for the Treatment of Moderate-to-Severe Plaque Psoriasis in the European Union

LEO Pharma today announced that the European Commission has granted marketing authorisation for Kyntheum® (brodalumab), a new biologic for the...


30 Jun, 2017, 13:00 BST Debiopharm International SA and Arbor Pharmaceuticals, LLC Announce U.S. FDA Approval for Triptodur™, Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP)

Triptodur™, (triptorelin) for extended release injectable suspension, has been shown to arrest or reverse the clinical signs of puberty with...


28 Jun, 2017, 21:00 BST Norgine Announces FDA Filing Acceptance for PLENVU® (NER1006)

Launch date set for first quarter 2018 Norgine B.V. today announced that it has received acceptance from the US Food and Drug Administration...


12 Jun, 2017, 09:05 BST FDA Approves BioMarin's Manufacturing Facility Located in Shanbally, Cork, Ireland

Ongoing Expansion of Facility Furthers Commitment to Irish Manufacturing BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today The...


12 Jun, 2017, 06:30 BST New Immunoassay for Detection of Buprenorphine and Three Major Metabolites

Thermo Scientific™ CEDIA® Buprenorphine II Assay received FDA 510(k) clearance and CE Mark EuroMedLab -- A new immunoassay for the specific...


08 Jun, 2017, 22:54 BST Endo Response to June 8, 2017 FDA Meeting Related to OPANA® ER

Endo International plc (NASDAQ: ENDP) is aware of today's announcement by the U.S. Food and Drug Administration (FDA) requesting that Endo...


06 Jun, 2017, 10:30 BST OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters

Announcement marks company's official entry into the US market OrbusNeich, a global company specializing in the provision of life-changing...


01 Jun, 2017, 15:05 BST Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients

- More than 1.6 million people die globally from lung cancer each year.1 - ALK – anaplastic lymphoma kinase – is an important...


01 Jun, 2017, 14:00 BST GenePOC Announces FDA Clearance for Revogene™ Instrument and its GBS LB Test

GenePOC announces it received 510(k) clearance from the US Food and Drug Administration to market its first molecular assay to detect Group B...


31 May, 2017, 21:05 BST Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority...


30 May, 2017, 10:00 BST Chinese Infant Milk Powder Won Three Successive Gold Awards in "Monde Selection"

People.cn recently launched a report on Feihe awarded the 2017 "Monde Selection" champion. The full report is as follow: The 2017 award ceremony...


30 May, 2017, 08:00 BST AMO Pharma Announces FDA Fast Track 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...