Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

OKAMI MEDICAL: Announces Major Milestones: FDA 510(k) Clearance And Key Patent For The LOBO Vascular Occluder

Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets

LUYE PHARMA: LY03004 Manufacturing Facility Successfully Passes U.S. FDA Pre-approval Inspection with Zero Observation

LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market.

SUNTIVA: Wins 10 BPA Orders with FDA Worth More Than $9 Million

Suntiva, a trusted advisor to leaders in achieving critical business transformation outcomes, is proud to announce that it recently won ten BPA orders with the U.S. Food and Drug Administration (FDA), with a total value of more than $9 million.

FLOWONIX MEDICAL: Receives FDA Approval for its Prometra II® 40 mL Programmable Pump System

Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software.

HKBU: HKBU Drug the First in Hong Kong to be Granted Orphan Drug Designation by the US FDA

A research team from the School of Chinese Medicine at Hong Kong Baptist University (HKBU) has successfully developed a novel aptamer, i.e. a single-stranded piece of DNA, for the treatment of osteogenesis imperfecta (OI) with the aid of artificial intelligence (AI) technology. It is the first time a drug in Hong Kong has been granted orphan drug designation by the US Food and Drug Administration (FDA).

FDA approved record number of generic drugs in 2018

A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.

HERON THERAPEUTICS: Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.

UNITED THERAPEUTICS: Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study

United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).

SHIONOGI: U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections

Shionogi & Co., Ltd. (hereafter “Shionogi”) announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

MD Anderson's Hahn a frontrunner for FDA Commissioner

Stephen Hahn, M.D., Chief Medical Executive of The University of Texas MD Anderson Cancer Center, is the top candidate to be the next commissioner of the U.S. Food and Drug Administration (FDA).

SUBTLE MEDICAL: Receives FDA 510(k) Clearance for AI-Powered SubtleMR™

Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an image processing software that uses denoising and resolution enhancement to improve image quality.

WONTECH: Receives FDA Clearance for 'HairBoom Air'

WONTECH (Reno Kim, CEO of WONTECH, www.wtlaser.com) a leading Korean laser and energy based medical aesthetic device company announced that its LLLT hair loss treatment device, HairBoom Air, received U.S. Food and Drug Administration 510(K) clearance.

THINK SURGICAL: Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States

Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application

FDA Update: recent animal drug approvals

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

Taxpayers Protection Alliance recommends FDA reforms

The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.

FDA Reporter