Friday, April 19, 2024

Friday, April 19, 2024

FDA Approval

FDA Approval

EndBrainCancer Initiative urges support, offers amendments

By Keri Carbaugh | Aug 9, 2019

FDA Approval

PERFUZE: Receives Breakthrough Device Designation Status from U.S. Food and Drug Administration (FDA) for Millipede CIS (Clot Ingestion System)

By Press release submission | Aug 9, 2019

FDA Approval

DALENT MEDICAL: Sinusleeve™ Balloon Device Completes FDA Listing, Dalent Medical Begins Sales In South Florida

By Press release submission | Aug 6, 2019

Latest News

INOTREM: Announces FDA Clearance of Investigational New Drug (IND) for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy

FDA Approval

By Press release submission | Aug 6, 2019

Inotrem S.A., a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for the ASTONISH trial (Phase IIb) where the safety, tolerance and efficacy of nangibotide (LR12), its lead compound for septic shock, will be studied.

PHYSIQ INC.: Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers

FDA Approval

By Press release submission | Aug 2, 2019

FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms

MEDICREA: Announces FDA Clearance of TULIP GENESIS to Complete its UNiDTM ASI platform technology

FDA Approval

By Press release submission | Aug 2, 2019

The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best Market – MRNTF), pioneering the digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that it has received FDA-Clearance for TULIP GENESIS™ which completes its UNiD™ ASI platform technology.

Court orders FDA to reconsider final approval of Brixadi

FDA Approval

By Keri Carbaugh | Aug 1, 2019

A December 2018 decision by the Food and Drug Administration (FDA) to block the final approval of a product from Braeburn Pharmaceuticals for the treatment of opioid use disorder has been vacated.

Despite Right to Try Act, ALS patients still desperately wait for fatal disease drug treatments

FDA Approval

By Chris Adams | Aug 1, 2019

People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.

MERCK: FDA Approves New Monotherapy Indication for Merck’s KEYTRUDA® (pembrolizumab)

FDA Approval

By Press release submission | Aug 1, 2019

KEYTRUDA Now Approved for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus in Patients Whose Tumors Express PD-L1 (CPS ≥10) With Disease Progression After One or More Prior Lines of Systemic Therapy

IMPOSSIBLE FOODS: Receives Approval for Its Color Additive Petition From US Food and Drug Administration

FDA Approval

By Press release submission | Aug 1, 2019

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DALLAS NEPHROLOGY ASSOCIATES: DNA Vascular Center is the First in Texas to Create Non-Surgical Dialysis Fistulas Using Two FDA-Approved Systems - Ellipsys® and WavelinQ™

FDA Approval

By Press release submission | Jul 31, 2019

Interventional Nephrologist Neghae Mawla, MD, pioneers minimally invasive fistula creation in Texas

Republican senators introduce innovation-driven drug-treatment bill; brace for resistance from FDA

Regulation

By John Severance | Jul 31, 2019

Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.

DMT LTD: Alfa Plus by Solio Receives FDA Clearance: Unique Device Delivers Pain Relief Without Pharmaceuticals

FDA Approval

By Press release submission | Jul 30, 2019

Solio (https://www.soliotherapy.com/) recently announced the release of its innovative Alfa Plus, after receiving FDA clearance.

CoolTone Device receives FDA approval

FDA Approval

By Keri Carbaugh | Jul 28, 2019

The CoolTone device from Allergan received Food and Drug Administration approval for use in improving abdominal tone and strength. CoolTone is already approved for strengthening, toning and firming of the buttocks and thighs.

CORREVIO PHARMA CORP: U.S. FDA Accepts Correvio's Resubmitted New Drug Application For Brinavess (vernakalant)

FDA Approval

By Press release submission | Jul 26, 2019

NDA Seeks Approval for Brinavess for the Treatment of Recent Onset Atrial Fibrillation; PDUFA Date Set for December 24, 2019

New drug application for Brinavess submitted to FDA

FDA Approval

By Keri Carbaugh | Jul 25, 2019

A New Drug Application (NDA) was resubmitted by Correvio Pharma Corporation to the Food and Drug Administration for the approval of Brinavess.

SOLITON, INC.: Soliton's FDA Cleared Device is Granted Key Patent

FDA Approval

By Press release submission | Jul 25, 2019

European Patent Office Approves Core Patent Covering Soliton's RAP Technology

MIRUS: First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance

FDA Approval

By Press release submission | Jul 24, 2019

MiRus™ Receives FDA 510(k) Clearance for the GALILEO™ Spine Alignment Monitoring System

WATER STREET HEALTHCARE PARTNERS: Water Street's Partnership with Leading Medical Products Company Leads to FDA Approval of the First and Only Ready-to-Use Insulin for IV Infusion

FDA Approval

By Press release submission | Jul 23, 2019

Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of Insulin Human in 0.9% Sodium Chloride Injection (Insulin Human).

MED-EL: FDA Approves MED-EL USA’s Cochlear Implants for Single-Sided Deafness and Asymmetric Hearing Loss

FDA Approval

By Press release submission | Jul 22, 2019

MED-EL’s are the First and Only Cochlear Implants to Be Granted Indications for Traditionally Underserved Population

FDA Reporter