Thursday, April 18, 2024

Thursday, April 18, 2024

FDA Approval

FDA Approval

FDA approved record number of generic drugs in 2018

By Bree Gonzales | Oct 24, 2019

FDA Approval

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)

By Press release submission | Oct 22, 2019

FDA Approval

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

By Press release submission | Oct 21, 2019

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

FDA Approval

By Press release submission | Oct 17, 2019

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

FDA Approval

By Bree Gonzales | Oct 16, 2019

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™

FDA Approval

By Press release submission | Oct 15, 2019

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.

SOLITON, INC.: Soliton's FDA Cleared RAP Device is Granted Two Additional Key Patents

FDA Approval

By Press release submission | Oct 15, 2019

Rapid Acoustic Pulse device granted patents in Taiwan and Japan

WONTECH: Receives FDA Clearance for 'HairBoom Air'

FDA Approval

By Press release submission | Oct 14, 2019

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

FDA Approval

By Press release submission | Oct 12, 2019

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

FDA Update: recent animal drug approvals

FDA Approval

By FDA Reporter Submission | Oct 12, 2019

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

FDA Approval

By Colin Froment | Oct 10, 2019

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 awards $15 million grant to 12 new clinical trials for rare-disease treatments

Regulation

By Bree Gonzales | Oct 9, 2019

Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.

FDA awards more than $4.1 million for natural history studies of rare diseases

FDA Approval

By Bree Gonzales | Oct 9, 2019

The U.S. Food and Drug Administration (FDA) is providing more than $4.1 million in the next four years to fund two natural history studies of rare diseases.

INTARCIA THERAPEUTICS: Provides Regulatory Update - FDA Accepts Resubmitted New Drug Application For ITCA 650

FDA Approval

By Press release submission | Oct 9, 2019

Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.

SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the Acucy™ Influenza A&B Test

FDA Approval

By Press release submission | Oct 9, 2019

Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy Reader.

CEPHEID: Receives FDA Clearance for Xpert® BCR-ABL Ultra Test

FDA Approval

By Press release submission | Oct 3, 2019

Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)

LUMINEX: Receives FDA 510(k) Clearance for the ARIES® MRSA Assay

FDA Approval

By Press release submission | Oct 2, 2019

Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay.

Vaping illnesses caused by illegal substances, AVA says

Regulation

By Amanda Smith-Teutsch | Sep 27, 2019

As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.

CARDIOVASCULAR SYSTEMS, INC.: Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip

FDA Approval

By Press release submission | Sep 26, 2019

U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease

WEST CANCER CENTER: The first center in the country to offer the first FDA-approved Mesothelioma treatment in more than 15 years

FDA Approval

By Press release submission | Sep 25, 2019

A clinical study showed that the NovoTTF-100L™ System in combination with chemotherapy may help people with malignant pleural mesothelioma extend their lives

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FDA Reporter