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

Sep 20, 2018, 17:05 ET Vanda Announces Listing of a New HETLIOZ® Patent in the FDA Orange Book

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that a HETLIOZ® patent, number 10,071,977 ('977 patent), is now listed in the U.S....


Sep 20, 2018, 05:00 ET FDA Clears Augmented Reality Visualization Solution GLOW800

Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its augmented reality GLOW800 surgical...


Sep 19, 2018, 05:00 ET OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


Sep 18, 2018, 16:30 ET Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and...


Sep 18, 2018, 15:13 ET FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid ...


Sep 18, 2018, 08:45 ET 1st Wireless, Handheld, FDA-approved Ultrasound Device to Offer Live Demos at FMX (Family Medicine Experience) 2018, Booth #722

Healcerion today announced the SONON 300L will be unveiled to the US market with live demos at booth #722 in the New Exhibitor Pavilion at FMX Family ...


Sep 18, 2018, 08:10 ET Contego Medical Receives 510(k) Clearance for the Paladin Carotid PTA Balloon System with Integrated Embolic Protection

Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated...


Sep 18, 2018, 08:05 ET FDA Approves PhageGuard-E as New Food Processing Aid Against E. Coli O157

FDA & USDA announced they have approved Phageguard-E as a "GRAS" (Generally Recognized as Safe) food processing aid against E.coli O157. The new...


Sep 17, 2018, 10:35 ET Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral...


Sep 17, 2018, 09:00 ET Anti-migraine Head Patch - HeadaTerm - Receives FDA Clearance

WAT Medical's innovative technology to treat all primary headaches, HeadaTerm, received its FDA clearance in September 2018. This product, already...


Sep 17, 2018, 08:01 ET U.S. FDA Clears Sebacia Microparticles for the Treatment of Mild to Moderate Inflammatory Acne

Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced that the U.S. Food and Drug Administration...


Sep 17, 2018, 08:00 ET Halozyme Announces Approval Of Subcutaneous Formulation Of Trastuzumab (Herceptin®) In Canada

Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of ...


Sep 14, 2018, 13:26 ET Every Second Counts: BIOTRONIK's PK Papyrus Stent for Coronary Perforations Approved for Use in the US

BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the...


Sep 14, 2018, 12:45 ET FDA approves device for treatment of acute coronary artery perforations

The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of...


Sep 13, 2018, 14:18 ET FDA approves new kind of treatment for hairy cell leukemia

The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult...


Sep 13, 2018, 10:00 ET Olympus Introduces EZ Shot 3 Plus 25 G EUS Needle with Enhanced Maneuverability for Uncompromised Access to Any Lesion, Consistent Performance to Potentially Reduce Procedural Costs and Procedure Time

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core...


Sep 13, 2018, 08:00 ET FDA Approves CroFab® Product Improvements

BTG plc (LSE: BTG) announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab® Crotalidae Polyvalent...


Sep 13, 2018, 06:30 ET Ardelyx Submits New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C to U.S. Food and Drug Administration

Ardelyx, Inc. (Nasdaq: ARDX), today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)...


Sep 12, 2018, 07:30 ET Amneal Announces FDA Approval and Launch of Generic Chlorpromazine Hydrochloride Tablets USP and Approval of Methylergonovine Maleate Tablets USP

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New...


Sep 12, 2018, 06:00 ET Exact Imaging Announces Health Canada Approval for its FusionVu™ Application for Micro-Ultrasound/MRI Fusion

ExactVu™ micro-ultrasound platform - - now with FusionVu - - enables the highest real-time resolution for targeted prostate imaging and biopsy...


Sep 12, 2018, 00:59 ET FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental...


Sep 10, 2018, 18:03 ET FDA Designates AliveCor's Bloodless Hyperkalemia Test a "Breakthrough Device"

AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration...


Sep 10, 2018, 15:30 ET Black Soldier Fly Larvae Ingredients Receive FDA Recommendation for Poultry Diets

The U.S. Food and Drug Administration (FDA) has recommended amendment of the Association of American Feed Control Officials (AAFCO) ingredient...


Sep 10, 2018, 15:12 ET Genesys Spine releases AIS-C Stand-Alone System

Genesys Spine is pleased to announce the FDA clearance of our latest product line, the AIS-C Stand-Alone System. The AIS-C Stand-Alone system is a...


Sep 07, 2018, 09:05 ET Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Imodium® Multi-Symptom Relief

Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug administration for the store...