Tuesday, April 30, 2024

Tuesday, April 30, 2024

Latest News

SHINKEI THERAPEUTICS: FDA Accepts SHINKEI Therapeutics Investigational New Drug Application for MR-301 for Traumatic Brain Injury

Regulation

By Press release submission | Aug 30, 2019

SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.

KAROLINSKA DEVELOPMENT AB: Karolinska Development's portfolio company Promimic receives FDA approval for its HAnano Surface® on a spinal implant

FDA Approval

By Press release submission | Aug 30, 2019

Karolinska Development's portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA.

Taxpayer Protection Alliance: Get behind gene therapy revolution

FDA Approval

By Zeta Cross | Aug 30, 2019

For millions of people who suffer from debilitating diseases, experimental gene therapies hold much promise.

Ningbo Huize Commodity receives FDA warning for quality control failures

Regulation

By Keri Carbaugh | Aug 30, 2019

Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.

New study says The Real Cost smoking prevention program saves 587,000 youths from smoking

Regulation

By Keri Carbaugh | Aug 29, 2019

The Food and Drug Administration’s “The Real Cost” campaign prevents 587,000 youth from starting smoking and saves more than $53 billion, according to a new study in the American Journal of Preventive Medicine.

AVRA MEDICAL ROBOTICS: Initiates Food and Drug Administration Approval Process

Reform

By Press release submission | Aug 29, 2019

AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced that its regulatory and management teams met with the Food and Drug Administration (FDA) on August 12th.

CONCEPT MEDICAL INC.: Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

FDA Approval

By Press release submission | Aug 29, 2019

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.

FDA issued 18 warning letters to companies in August

Regulation

By FDA Reporter Submission | Aug 29, 2019

The U.S. Food and Drug Administration issued 18 warning letters in August that were sent to manufacturers and other companies found to have violated FDA regulations.

4WEB MEDICAL: Announces FDA 510(k) Clearance of its Cervical Stand-Alone Interbody Fusion Device

FDA Approval

By Press release submission | Aug 28, 2019

Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone

U.S. FDA: Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Patients

By Press release submission | Aug 28, 2019

Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves.

APIFIX: Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents

Patients

By Press release submission | Aug 27, 2019

FDA approves ApiFix’s unique self-adjusting pediatric device designed to benefit young scoliosis patients with a less invasive surgical treatment

U.S. FDA: Requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks

Patients

By Press release submission | Aug 27, 2019

The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida.

DISCGENICS: Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration

Regulation

By Press release submission | Aug 26, 2019

DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the U.S. and Japan for the reduction in pain and disability associated with degenerative disc disease (DDD), a major cause of chronic low back pain.

BIOBEAT: First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure

FDA Approval

By Press release submission | Aug 26, 2019

Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat's products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

FDA reviews data manipulation in AveXis' new gene therapy drug for children

FDA Approval

By Kayla Elder | Aug 25, 2019

One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.

FDA warning about the side effects of Miracle Mineral Solution

FDA Approval

By Keri Carbaugh | Aug 24, 2019

The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.

New cloud-based vital signs measurement system approved by FDA

FDA Approval

By Keri Carbaugh | Aug 24, 2019

The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.

FDA to unveil new warning labels for cigarettes

Regulation

By John Severance | Aug 24, 2019

The U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.

SEELOS THERAPEUTICS: Announces FDA Acceptance of IND Application for SLS-005 for Mucopolysaccharidosis Type III (Sanfilippo Syndrome)

FDA Approval

By Press release submission | Aug 23, 2019

Seelos to Proceed with Trial Enrollment and Dosing for Phase IIb/III Trial for Sanfilippo Syndrome Type A and B Patients

MIRACOR MEDICAL: Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

FDA Approval

By Press release submission | Aug 23, 2019

Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients.

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  1. 1 ASTELLAS PHARMA INC.: U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
FDA Reporter