Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

U.S. FDA: Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts

The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).

THE AMERICAN ACADEMY OF STEM CELL PHYSICIANS: Dr. A.J. Farshchian, Spokesperson for AASCP, Recommends FDA Safety Panel Discussion This Weekend

AASCP is hosting an FDA Panel and many distinguished physicians this weekend at their annual Scientific Congress. All physicians practicing stem cell treatments should not miss this event on Nov. 1-3, 2019.

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.

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

CORREVIO: Announces FDA Advisory Committee Meeting to Review Brinavess™ for Recent Onset Atrial Fibrillation

Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).

COMPUGEN: Announces FDA Clearance of IND Application for COM902

Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020

CEFALY TECHNOLOGY: U.S. Military Gains Quicker Access to Migraine Relief through FDA-Cleared CEFALY Technology

A new partnership between CEFALY Technology and QB Medical puts wearable medical devices in the hands of health care providers and grants active military immediate relief from migraine headaches

Proposed FDA vaping regulations are 'extensive, outdated,' AVA president says

Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.

ANABIOS: FDA Awards AnaBios Contract to Obtain Critical Translational Data from Ex Vivo Human Cardiac Platform

The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.

VYAIRE MEDICAL: Proven bellavista™ 1000e Ventilator System Receives FDA Clearance

Innovative ventilation system that can be used across health care settings for full range of patients

CAMURUS: Announces That FDA Grants Braeburn's Citizen Petition, Eliminating the Risk of Further Blocking of Brixadi™ From the US market

Camurus AB (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocade™.

UVISION360: Innovative Femtech Medical Device Company Receives Third FDA Clearance; Expands Choices for LUMINELLE System

UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360˚ Rotatable Disposable Sheath (Diagnostic).

AI MEDICAL SERVICE INC.: Announces FDA Breakthrough Device Designation for endoscopic AI system

AI Medical Service Inc., one of the world's first real-time endoscopic artificial intelligence (AI) developers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI programs that analyze endoscopy images for potential diagnosis of gastric cancer.

IRRAS: Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.

FDA Reporter