Latest News from FDA Reporter

By Press release submission | Dec 6, 2019

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

By Press release submission | Dec 6, 2019

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement

U.S. FDA: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

By Press release submission | Dec 5, 2019

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.

INNOVENT BIOLOGISTICS: Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Patients

By Press release submission | Dec 3, 2019

Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced that the new drug application ("NDA") submitted by Incyte to the U.S. Food and Drug Administration ("FDA") for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.

SECTRA: Sectra and Leica Biosystems Partner to Pursue FDA Clearance for an Integrated Clinical Digital Pathology Solution

Reform

International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution.

U.S. FDA: FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Clinic had significant donor eligibility violations, including donor screening and testing

U.S. FDA: California-based food manufacturer agrees to stop production after repeated food safety violations

The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

U.S. FDA: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

U.S. FDA: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.

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

By Press release submission | Nov 24, 2019

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.

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

Reform

By Press release submission | Nov 11, 2019

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.

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

By Press release submission | Nov 8, 2019

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).

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

Drug Shortages

By Press release submission | Nov 8, 2019

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™.

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

By Press release submission | Nov 7, 2019

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

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

By Press release submission | Nov 7, 2019

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.

LUMINEX CORPORATION: Reports Third Quarter 2019 Results and Submission of VERIGENE II Gastrointestinal Flex Assay to the FDA

By Press release submission | Nov 6, 2019

All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").

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