The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines
Latest Developments, Breakthroughs & Future Outlook
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Medical Devices and Biotechnology News
Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
Acceptance reinforces Fresenius Kabi’s strategy to expand its autoimmune biosimilars portfolio and broaden patient access to biologic medicines
Teleflex Medical OEM Launches as INGENYX to Empower Tomorrow’s MedTech Innovators
Combining leading in-house expertise with platform-enhancing investments to accelerate advances in engineering, innovation and manufacturing capabilities serving global medical device innovators
Effective August 1, 2026, the agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for BRIJ-SEAL™, joining BRIJ Medical's existing Premier Breakthrough Technology designations for Brijjit® BP-100 and Brijjit® BP-75 Force Modulating Tissue Bridges
The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase.
This collaboration is a strong strategic and financial fit for Vector," said William Jackson, CEO of Vector Science & Therapeutics Corp. and CEO of LyoGenesis Plus
Clinical Trials | Funding | Mergers & Acquisitions | Market Reports
1st Published Clinical Study Demonstrates Feasibility of Fluorescence Imaging in Orthopaedic Surgery
The Royal Orthopaedic Hospital NHS Foundation Trust researchers publish the first clinical evidence supporting the use of real-time fluorescence imaging during revision knee arthroplasty for periprosthetic joint infection
The acquisition deepens Ouma's clinical network across New England and advances its national strategy to expand access to MFM care close to home
FLASH program, in collaboration with GE HealthCare, to support development of faster, distributed DNA manufacturing for next-generation therapies
Jascayd: EU approval marks new chapter in pulmonary fibrosis, says GlobalData
Jascayd is a first-in-class phosphodiesterase 4B (PDE4B) inhibitor that has been designed to have isoform selectivity to retain the antifibrotic and anti-inflammatory effects of PDE4 inhibition while avoiding the tolerability constraints that have limited previous nonselective PDE4 inhibitors in respiratory diseases
Executives On the Move
Industry Expert Bylines
Dr Mohammad Dastjerdi brings deep expertise in the medical and surgical management of complex corneal and ocular surface disease, including corneal transplantation, dry eye disease, and corneal neovascularization. He joins as an associate professor and will treat patients through the NYU Langone Eye Center
CIRCA Scientific Appoints Jack Darby as Chief Executive Officer
Veteran cardiovascular medical device executive to lead Company's next phase of growth as CIRCA builds a differentiated cardiovascular access portfolio; Lee Geist transitions to Chief Operating Officer
Caristo Diagnostics Expands Executive Team With 2 Experienced Leaders
David Vort Chief has been appointed Commercial Officer and Chris Louk Chief Financial Officer
The ROADSAVER Stent System is a next-generation design featuring an innovative, dual-layer nitinol micromesh construction. The outer self-expanding nitinol scaffold provides strength and flexibility, while the inner micromesh layer serves as a continuous embolic barrier – helping to contain plaque against the vessel wall and minimize distal embolization during and after the procedure. Read what our expert has to say:
Medical devices have evolved to the point where they no longer operate as standalone products. As these products become more connected, materiovigilance, the process of monitoring and evaluating the safety and performance of medical devices after they reach the market, is becoming increasingly complex.
Hospitals
Imaging
Association News
BayCare Among First in Florida to Offer Next-Generation Breast Surgery Procedure
As BayCare continues to advance breast cancer care, robotic-assisted nipple-sparing mastectomy offers eligible patients another innovative option tailored to their medical and personal needs
Former First Baptist Medical Center Acquired By St Raphael Health – Dallas
The new ownership brings a renewed team, a more welcoming hospital experience, and stronger connections for Dallas patients, surgeons, physicians, families, and community partners
Florida's first installation and utilization of the groundbreaking spatial computing platform enables a radiation-free, image-fusion percutaneous liver biopsy — signaling a new era of merged-reality, 3D image-guided intervention
HOPPR's fifth foundation model brings its own chest CT capability to the AI Foundry portfolio, combining purpose-built models with secure infrastructure and flexible expert services that meet development teams wherever they are
The 2027 AAMI neXus will be the premier gathering of the medical device, safety, and regulatory professionals whose work drives safety and innovation in international health technology
ACC to Launch New Cardiogenic Shock Designation to Address Deadly Gap in Heart Attack Care
Additionally, a new grant will support rural hospitals in implementing designation
