| FDA Reporter

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.

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

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

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.

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

By Press release submission | Aug 28, 2019

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

FDA issued 18 warning letters to companies in August

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.

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

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.

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.

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

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.

Ningbo Huize Commodity receives FDA warning for quality control failures

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.

Taxpayer Protection Alliance: Get behind gene therapy revolution

By Zeta Cross | Aug 30, 2019

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

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

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.

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

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.

U.S. FDA: Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

By Press release submission | Sep 3, 2019

A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree.

ASTEX PHARMACEUTICALS: Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA

By Press release submission | Sep 3, 2019

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

ARTHROSURVACE: Receives FDA Clearance for BOSS™ Toe Fixation System

By Press release submission | Sep 5, 2019

New joint preserving implant compatible with the Toe HemiCAP DF® and ToeMotion™ Systems

MEVION MEDICAL SYSTEMS: Mevion’s CBCT Imaging Solution from medPhoton Receives FDA Clearance

By Press release submission | Sep 5, 2019

The cutting-edge CBCT imaging system, an integrated solution with 2D and 3D imaging, is now available to Mevion systems in the U.S.

Applications for new drugs, biological products dip slightly in FY2019

By FDA Reporter Submission | Sep 5, 2019

New drug and biological product application filings were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

ICUS: Simple CEUS Scan Helps Diagnose Liver Cancer When MRI is Uncertain

By Press release submission | Sep 5, 2019

A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.

RIDGEBACK BIOTHERAPEUTICS LP: Announces receipt of Breakthrough Therapy designation from FDA for mAb114