U.S. FOOD AND DRUG ADMINISTRATION: Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
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GRIFOLS: Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies
Xembify® is Grifols' first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies
GILEAD SCIENCES, INC.: Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
Gilead Sciences, Inc. (NASDAQ: GILD) announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib.
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PREMIER INC.: Premier’s ProvideGx™ Program to Make the First FDA-Approved Version of Cysteine Hydrochloride Available to Providers
Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.
LUMINEX CORPORATION: Luminex Submits ARIES MRSA Assay for FDA Clearance
Luminex Corporation (NASDAQ: LMNX) announced that the company submitted the ARIES® MRSA Assay to the U.S. Food and Drug Administration (FDA) for clearance on Friday, June 28, 2019.
LANNETT COMPANY, INC.: FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application
Lannett Company, Inc. (NYSE: LCI) commented on the U.S. Food and Drug Administration's (FDA) denial of a Citizen Petition submitted by Genus Lifesciences requesting that the FDA refuse to accept any submissions related to Lannett's 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride Topical Solution, 4% and 10%.
U.S. FOOD AND DRUG ADMINISTRATION: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps
The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.
HALEIGH'S HOPE: Haleigh's Hope, Inc. Lab Receives FDA Compliant, GMP Certification on Manufacturing Practices for All Hemp CBD Products Manufactured by the Company
Haleigh's Hope is proud to announce that they received GMP (Good Manufacturing Practices) certification
U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting
In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
GEL-E, INC.: Breakthrough Device Designation received from the FDA
gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.
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ZEBRA MEDICAL VISION: Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage (ICH), based on head CT scans.
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BECTON DICKINSON AND COMPANY: BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA
U.S. FOOD AND DRUG ADMINISTRATION: Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
CARSGEN THERAPEUTICS: Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA
CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).
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MICROBIOME THERAPEUTICS INNOVATION GROUP: Statement on FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT
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U.S. FOOD AND DRUG ADMINISTRATION: Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products
Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993
BIO-TECHNE CORPORATION: FDA Grants Breakthrough Device Designation To Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test
Bio-Techne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation.