FDA Approvals

Found 11,841 articles

• Exceed Microneedling device first to receive FDA clearance for the treatment of wrinkles

  9/25/2018

  MT.DERM GmbH, Berlin, Germany, is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the brand amiea med, exclusively available to healthcare professionals.

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  FDA Action Alert: Merck, Insmed and Antares Pharma

  9/24/2018

  The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.

• Verastem Oncology Receives FDA Approval of COPIKTRA™ (duvelisib) Capsules

  9/24/2018

  Verastem Oncology (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has approved COPIKTRA™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

• Cook Medical Receives FDA Approval for First 5 mm Diameter SFA Drug-Eluting Stent

  9/24/2018

  Cook Medical announced that a new 5 mm diameter version of Zilver® PTX® was approved by the FDA.

• Boston Scientific Receives U.S. FDA Approval for the Eluvia™ Drug-Eluting Vascular Stent System

  9/24/2018

  First peripheral vascular interventional technology approved in the U.S. to offer sustained release of antiproliferative drug to treat patients with peripheral artery disease

• b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System

  9/21/2018

  b-ONE Ortho Corp. today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA).

• AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.

  9/21/2018

  Point-of-care regenerative medicine technology approved to treat second- and third-degree burns using Spray-On Skin™ Cells product

• Cardurion Pharmaceuticals Announces Initiation of Phase 1 Study of CRD-733, a PDE-9 Inhibitor in Development for the Treatment of Heart Failure

  9/20/2018

  Cardurion Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) for CRD-733

• TherapeuticsMD Announces the FDA has Granted AnnoveraTM Marketing Exclusivity as a New Chemical Entity

  9/20/2018

  TherapeuticsMD, Inc. has been granted marketing exclusivity as a new chemical entity (NCE) from the U.S. Food and Drug Administration.

• FDA Clears Augmented Reality Visualization Solution GLOW800

  9/20/2018

  Leica Microsystems receives FDA's 510(k) clearance for Augmented Reality GLOW800 Vascular Fluorescence

• UTILITY Receives Investigational New Drug Approval from US FDA

  9/19/2018

  UTILITY therapeutics Ltd today announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) applications for mecillinam (injectable) and pivmecillinam (oral prodrug).

• OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)

  9/19/2018

  Second Orphan Drug Designation for OBI-3424, a novel first-in-class targeted therapy for solid and liquid tumors that express aldo-keto reductase 1c3 (AKR1C3) enzyme

• Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

  9/18/2018

  Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the osteoconductive PEEK-OPTIMA® HA Enhanced material

• inui Health Announces the First Clinical Grade Diagnostics Test Accessible to Everyone, Anywhere in the World, From Their Smartphone

  9/18/2018

  As the first of its kind urine diagnostic panel to receive FDA approval, inui’s smartphone enabled platform immediately displays results of various diagnostic tests and has been validated in multiple clinical studies across the world.

• FDA Approves PhageGuard-E as New Food Processing Aid Against E. Coli O157

  9/18/2018

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

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  FDA Action Alert: Migraine Treatment Approved by the FDA, Ready to Roll in 2 Weeks

  9/17/2018

  The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’ Ajovy (fremanezumab) to prevent migraine on Friday, September 16.

• SpineVision® Receives FDA Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage

  9/17/2018

  Company’s newest product, designed to reduce risk of subsidence in disc height after back surgery, will be introduced to spine surgeons at “EuroSpine 2018” and “NASS 2018”

• Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule

  9/17/2018

  Oramed Pharmaceuticals Inc.announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for human trials of its oral GLP-1 analog capsule ORMD-0901.

• Venture Heat Announces FDA Clearance for New Infrared Heat Therapy Pain Relief

  9/17/2018

  FIR heat therapy is a type of low-energy therapy that takes advantage of heat generated by waves of energy from the far end of the infrared spectrum.

• U.S. FDA Clears Sebacia Microparticles for the Treatment of Mild to Moderate Inflammatory Acne

  9/17/2018

  U.S. Commercial Launch of Cash-Pay Product Anticipated in Mid-2019