Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “Our product design and engineering team developed a superior method for staple implantation that enhances surgical efficiency. About Tyber Medical LLC. Are you hiring?

Medical 98

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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Food and Drug Administration FDA Recruitment Food 98

Pharmaceutical Technology

JUNE 2, 2023

It has been engineered to remove certain sugar molecules generally expressed on the antibody. Last December, the US Food and Drug Administration (FDA) also granted approval to Briumvi to treat RMS in adult patients. The therapy targets a unique epitope on CD20-expressing B-cells.

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Food and Drug Administration Engineering Food Patients 98

PM360

AUGUST 29, 2022

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute. There are no shortcuts in drug development, and nor should there be.

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Legacy MEDSearch

JANUARY 10, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. . Food and Drug Administration (FDA). VERO Biotech Inc., About GENOSYL ® DS. Are you hiring?

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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Food and Drug Administration FDA Engineering Food 52

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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Pharmaceutical Technology

APRIL 11, 2023

The finding was made as part of a study published in the journal Nature Biomedical Engineering. Kelley added: “Engineering-based tools allow you to do things that open up new areas of biology. CTRL Therapeutics will file an application with the US Food and Drug Administration (FDA) to advance the new platform into clinical trials.

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Pharmaceutical Technology

FEBRUARY 14, 2023

It will also support smaller dose vials development, selection of strain as per the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market. It was developed using the recombinant nanoparticle technology of Novavax.

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Food and Drug Administration Government FDA Engineering 64

Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.

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Food and Drug Administration FDA Safety Engineering 52

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The difference is that purified water can be used for non-parenteral drugs, while WFI must be used for parenteral drugs.

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European Pharmaceutical Review

JULY 11, 2023

This news follows the US Food and Drug Administration (FDA)’s approval of the anti-cancer treatment last month. The T-cell-engaging BsAb is engineered to have one region that binds to CD3 and two regions that bind to CD20, which can be healthy or malignant.

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Pharmaceutical Technology

MARCH 8, 2023

The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products. Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies.

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Food and Drug Administration Manufacturing Engineering Food 97

Pharmaceutical Technology

APRIL 17, 2023

argenx engineers antibodies for therapeutic use in its Immunology Innovation Program (IIP). Argenx also has three Fc engineering technologies (NHANCE, ABDEG and POTELLIGENT) that it uses to expand its antibody portfolio. Vyvgart is also the first FDA-approved neonatal Fc receptor (FcRN) antagonist.

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. To learn more, visit: www.zetasurgical.com.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Social engineering attacks will rise, in addition to phishing, smishing and deepfake attacks.

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European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. Lecanemab is a humanised antibody generated using protofibrils engineered from Aβ harbouring genetic mutations that cause familial AD.

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Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. .” Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

OCTOBER 27, 2022

Taysha develops and commercialises drug therapies for rare and large-market indications such as monogenic central nervous system (CNS) diseases. These innovative drugs offer potential for better, more effective treatments for Rett syndrome and GAN. It is in Phase I/II clinical development and awaiting regulatory feedback.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Legacy MEDSearch

AUGUST 22, 2022

Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As With FDA clearance, clinicians and patients everywhere can trust MedWand’s vitals and remote examination tools, and experience telemedicine on an entirely new level.”

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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. Each engineered T cell batch is manufactured separately and infused back into the cancer patient.

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Food and Drug Administration FDA Manufacturing Engineering 52

European Pharmaceutical Review

MAY 4, 2023

Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? 2, 3 The treatment was engineered to simultaneously bind with high affinity and inhibit both EGFR and MET, which are two important pathways in NSCLC development and progression. Personalized medicine at FDA. Cancer Ther.

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Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

MAY 30, 2023

Food and Drug Administration (FDA). About Sagentia Innovation Sagentia Innovation is a science and engineering R&D consultancy based in Cambridge, U.K. The post THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System appeared first on Legacy MedSearch | Medical Device Recruiters.

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Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. The post FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

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Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.

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FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

JULY 26, 2024

More about the gene therapy The one-time gene therapy contains a “bio-engineered adeno-associated virus (AAV) capsid and a high-activity variant of human coagulation FIX gene”, Pfizer shared. DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year.

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Food and Drug Administration Engineering Food Patients 52

Legacy MEDSearch

FEBRUARY 3, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Food and Drug Administration (FDA).

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

European Pharmaceutical Review

FEBRUARY 24, 2023

The risks linked to contamination have led regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to implement strict requirements on process characterisation and validation. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

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Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

Patients 52

Patients FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies. ABOUT REGELTEC, INC: ReGelTec, Inc. ABOUT REGELTEC, INC: ReGelTec, Inc. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.

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Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of its Zoom RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Imperative Care, Inc., announced U.S. Imperative Care is based in Campbell, Calif.

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

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