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Drug Delivery Device Articles & Analysis

17 news found

Biopharma PEG Achieves FDA DMF Approval for HZ-PEG-HZ

Biopharma PEG Achieves FDA DMF Approval for HZ-PEG-HZ

Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. ...

ByBiopharma PEG Scientific Inc


Huateng Pharma to Showcase Extensive PEG Derivatives and CDMO Capabilities at CPHI Japan 2025

Huateng Pharma to Showcase Extensive PEG Derivatives and CDMO Capabilities at CPHI Japan 2025

Key Product Highlights: · PEG Derivatives o A vast inventory of over 3000 high-quality PEG derivatives. o Monodispersed PEG linkers and multi-arm PEGs. o Scalable production from R&D to GMP commercial levels. o Applications spanning ADCs, PROTACs, LNP drug delivery, medical devices, and more. · Pharmaceutical Intermediates o ...

ByHunan Huateng Pharmaceutical Co. Ltd.


Peer reviewed publications reporting the effectiveness of the Kurve intranasal insulin product

Peer reviewed publications reporting the effectiveness of the Kurve intranasal insulin product

Nasaldrugdeliveryblog.com opens lines of communication between drug delivery researchers, device manufacturers. The first blog to address issues related to nasal drug delivery formulation, research, delivery, and devices was launched by Kurve Technology, Inc., a leading ...

ByKurve Therapeutics, Inc.


FDA Emerging Technology Program

FDA Emerging Technology Program

Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...

ByAktiv Pharma Group, Inc


ApiJect Systems Announces Investment by Royalty Pharma and Jefferies

ApiJect Systems Announces Investment by Royalty Pharma and Jefferies

ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. ...

ByApiJect Systems, Corp.


Berkshire Biomedical to Participate in the LSX 6th Annual Investment Showcase

Berkshire Biomedical to Participate in the LSX 6th Annual Investment Showcase

Berkshire Biomedical Corporation (“Berkshire” or “the Company”), focused on developing drug delivery devices designed to accurately and precisely deliver oral liquid drugs only to the biometrically authenticated Intended User, provide remote monitoring and enhance patient wellness, announced today that ...

ByBerkshire Biomedical


Berkshire Biomedical Recognizes International Overdose Awareness Day

Berkshire Biomedical Recognizes International Overdose Awareness Day

Berkshire Biomedical, LLC (“Berkshire” or “the Company”), focused on developing drug delivery devices designed to precisely deliver oral liquid drugs only to the biometrically authenticated Intended User, provide remote monitoring and enhance patient wellness, announces today that it joins with the ...

ByBerkshire Biomedical


Bexson Biomedical Granted USPTO Patent On Proprietary Ketamine Formulation

Bexson Biomedical Granted USPTO Patent On Proprietary Ketamine Formulation

Bexson Biomedical, Inc., a research-stage company developing therapies and delivery solutions for pain management, addiction and mental health indications, announced today that the U.S. ...

ByBexson Biomedical


Orchestra BioMed Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

Orchestra BioMed Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

Laughner served as the Associate Director, Combination Products at MedImmune, an AstraZeneca company, where he developed regulatory strategies and submissions for combination products in their biologic portfolio and developed strategies to evaluate the safety and effectiveness of drug delivery systems, including novel and wearable technologies. Prior to ...

ByOrchestra BioMed, Inc.


Concept Medical is Granted CE Certification for Sirolimus Coated MagicTouch Group of Products.

Concept Medical is Granted CE Certification for Sirolimus Coated MagicTouch Group of Products.

The currently accepted procedure is, to use drug delivery devices to deliver drugs that inhibit the inflammatory and proliferative pathways that lead to restenosis. Sirolimus is widely accepted as a drug of choice for such a purpose. Several studies have demonstrated that Erectile Dysfunction (ED) is ...

ByConcept Medical Inc.


Endomedix Joins US Army Medical Research Groups in CRADA for Ocular Projectile Battlefield Trauma Project

Endomedix Joins US Army Medical Research Groups in CRADA for Ocular Projectile Battlefield Trauma Project

“Endomedix has developed a novel polysaccharide chemistry platform that will be used to develop a series of differential biosurgical devices, ranging from game changing absorbable hemostats to specialty wound treatments to tissue sealants and sustained released devices. ...

ByEndomedix, Inc.


Endomedix publishes ground breaking research and method development for the use of biologically derived polysaccharides in implantable medical devices in peer reviewed journal

Endomedix publishes ground breaking research and method development for the use of biologically derived polysaccharides in implantable medical devices in peer reviewed journal

This article addresses the method development and verification necessary to use a variable natural material as a key component in a consistent medical device. “Working with natural biomaterials as components or substrates for medical devices holds great promise from the perspectives of biocompatibility, biodegradation and nontoxicity”, notes Richard ...

ByEndomedix, Inc.


Endomedix, Inc. to present its innovative technology addressing the needs of Warfighters at the upcoming Military Health System and Research Symposium 2019 annual meeting

Endomedix, Inc. to present its innovative technology addressing the needs of Warfighters at the upcoming Military Health System and Research Symposium 2019 annual meeting

Unlike currently available hemostats that require continuous manual pressure to be effective, the Endomedix device can spray or flow on without manual pressure and stays in place. ...

ByEndomedix, Inc.


Endomedix, Inc. to Present at Upcoming Society For Biomaterials 2019 Annual Meeting

Endomedix, Inc. to Present at Upcoming Society For Biomaterials 2019 Annual Meeting

“A recent review of published reports of hemostat device performance did not locate any findings about stable clot formation or coagulation produced by these hemostats”, added Ms. ...

ByEndomedix, Inc.


Endomedix, Inc. Announces Submission of Patent Application for Advanced Hemostat Technology

Endomedix, Inc. Announces Submission of Patent Application for Advanced Hemostat Technology

Though the underlying technology allows inclusion of drugs in the product formulation, the hemostat does not include any drugs or chemicals. ...

ByEndomedix, Inc.


Flowonix Medical Launches the Flowonix Maestro ProView Platform with First-of-a-Kind Reports Designed to Provide Programming Assurance

Flowonix Medical Launches the Flowonix Maestro ProView Platform with First-of-a-Kind Reports Designed to Provide Programming Assurance

"The ProView platform is an important step forward in improving safety in the field of targeted drug delivery," said leading interventional pain physician Anjum Bux, MD, from Lexington, Kentucky. ...

ByFlowonix Medical Inc.


Fretting Corrosion Causes Recall of Drug Delivery Medical Device

Fretting Corrosion Causes Recall of Drug Delivery Medical Device

This past November, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ikaria INOmax DS Drug Delivery System. The device is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ...

ByEMSL Analytical, Inc.

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