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Meeting rising demands of a new radiotheranostic era

European Pharmaceutical Review

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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Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

Legacy MEDSearch

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). ” CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. For additional important safety information, please see the CHG Instructions For Use.

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KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60® Infusion System With Hizentra® 50 Ml Prefilled Syringes

Legacy MEDSearch

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

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Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® to Coagulate and Contract Soft Tissues

Legacy MEDSearch

Apyx Medical Corporation (NASDAQ:APYX) , the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion ® , today announced it has received 510(k) clearance from the U.S. Renuvion ® and J-Plasma ® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results.

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Microbiome therapies: a maturing movement

European Pharmaceutical Review

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Legacy MEDSearch

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

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