OCTAPHARMA USA: FDA Approves New Octaplas™ Product Label
New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients
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REGENXBIO: Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform
FDA approval of Novartis' ZOLGENSMA for the treatment of pediatric patients with SMA marks the first regulatory approval based on REGENXBIO's NAV Technology
FDA warns of unapproved diabetes devices
In a safety communication released last week, the Food and Drug Administration warned against unapproved and unauthorized devices for diabetes.
EPIBONE, INC.: Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF
Potential breakthrough technology for stem-cell based bone replacement
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THINK SURGICAL, INC.: Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures
THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement procedures.
Former commissioners promote idea of an independent FDA
This week, Eli Adashi, Rohit Rajan, and Glenn Cohen will have another paper published in Science that says the FDA is being undermined because of politically motivated congressional legislators, especially recently.
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development.
U.S. FOOD AND DRUG ADMINISTRATION: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions
U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
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MEDICAL MARIJUANA, INC.: CEO Chosen to Present Oral Comments at FDA's Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds
Medical Marijuana, Inc. (OTC: MJNA), the first publicly traded cannabis company in the United States, announced today that the Company's CEO, Dr. Stuart Titus, has been chosen as one of 65 speakers to present oral comments at the U.S. Food & Drug Administration (FDA)'s upcoming public hearing discussing scientific data and information about products containing cannabis-derived compounds.
PERRIGO COMPANY PLC: Announces FDA Final Approval For AB Rated Generic Version Of Voltaren® Gel 1%
Perrigo Company plc (NYSE; TASE: PRGO) announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%).
SOLITON INC.: Provides FDA Update and Addresses Recent Anonymous Article
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), provided an update on its application for FDA clearance and addressed a recent anonymous article published on SeekingAlpha.com.
ZEBRA MEDICAL VISION: Zebra Medical Vision Receives FDA Approval for World's First AI Chest X-ray Triage Product
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning imaging analytics company, announces that it has received FDA 510(k) clearance for HealthPNX - an AI alert for pneumothorax (PNX), based on chest X-rays.
TRACELINK, INC.: FDA Approves TraceLink DSCSA Pilot Submission for Network Solutions; Delivering 2023 Traceability By Leveraging Blockchain and Digital Recalls Across a Supply Network
TraceLink Inc., the world's largest integrated digital supply network providing real-time information sharing for better patient outcomes, announced the acceptance of its participation in the Food and Drug Administration (FDA) Pilot Project Program under the Drug Supply Chain Security Act (DSCSA).
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EMURMUR: FDA grants clearance for a heart murmur detection solution on a personal mobile device
eMurmur ID is an artificial intelligence-based solution that enables healthcare providers to detect and classify heart murmurs with expert-level accuracy
First treatment approved for children with Lambert-Eaton myasthenic syndrome
Children aged 6-17 with the autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS) have the first treatment for their disease with the Food and Drug Administration-approved Ruzurgi.
New treatments for transthyretin mediated amyloidosis approved
Two new medicines, Vyndaqel and Vyndamax, were approved for adults by the Food and Drug Administration earlier this month. They will help to treat heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
AMDT HOLDINGS, INC.: Gains FDA Clearance for SixFix™ Hexapod Device
Innovative external fixator shortens surgical time, simplifies inventory, and enhances patient care.
IDLOGIQ INC: IDLogiq® Innovations Selected by FDA DSCSA Pilot Project Program to Address National Security of Drug Supply Chain
IDLogiq® innovations have been selected by the Food and Drug Administration (FDA) for the Pilot Project Program under the Drug Supply Chain Security Act (DSCSA) to prototype and develop a system that can address the national security of the drug supply chain and future interoperability of secure electronic information exchange.
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ORSENSE LTD.: FDA Grants Market Clearance for the OrSense NBM200; the First Noninvasive Hemoglobin System Cleared for Use in Blood Donation Centers
OrSense Ltd., a leading developer of systems for non-invasive measurements of Hemoglobin, today announces that its NBM200 non-invasive Hemoglobin measurement device has received FDA/CBER 510(K) clearance for use in blood banks
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U.S. FOOD AND DRUG ADMINISTRATION: FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards
The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.