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.
Guidance for premarket tobacco product applications for electronic nicotine delivery systems finalized
The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.
FDA Update: Which drugs are in short supply?
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
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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).
Physician praises FDA plans to further assist doctors obtain experimental cancer treatments
WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
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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.
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COHLEAR LIMITED: FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.
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HI-TECH PHARMACEUTICALS, INC.: The Government and FDA Ordered to Return Five Truckloads of DMAA to Hi-Tech Pharmaceuticals
Jared Wheat, CEO of Hi-Tech Pharmaceuticals, released the following statement in response to the return over $19 million worth of DMAA to Hi-Tech Pharmaceuticals
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TRINETX: Applauds House Appropriations Committee for Supporting Use of Real-World Evidence in House Agriculture-FDA Spending Bill
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), praised the House Appropriations Committee for approving its fiscal year 2020 Agriculture, Rural Development, FDA, and Related Agencies bill which includes support for the use of RWE in regulatory decision making.
IBM, KPMG, Merck and Walmart to collaborate as part of FDA's program to evaluate the use of blockchain to protect pharmaceutical product integrity
The FDA pilot program explores innovative and emerging approaches for the tracing and verification of prescription products
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ARATANA THERAPEUTICS: Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial
Commercial availability of NOCITA 10 mL vial size anticipated by fall 2019
EMCYTE CORPORATION: Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System.
Emerging biotech firms rival big pharma in new drug development, study finds
Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.
Are price controls the answer when it comes to gene therapy drugs?
Some believe with the advent of gene therapy, the future of medicine has been seen.