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BIOTECHNOLOGY

Medical Device News Magazine reports breaking biotechnology news including new biotech developments, pharmaceuticals and more.

Curium Receives Positive CHMP Opinion of PYLCLARI® for Primary Staging of Patients With High-Risk PCa Prior to Initial Curative Therapy and to Localize Recurrence of PCa in Patients With a Suspected Recurrence Based on Increasing Serum Prostate-Specific Antigen (PSA) Levels After Primary Treatment With Curative Intent

f approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging notes Curium.

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Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023

EMERALD Clinical Study is a Phase 3 registrational trial that demonstrated statistically significant PFS with elacestrant versus SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane). Based on these results, the U.S. Food & Drug Administration (FDA) approved ORSERDU (elacestrant) on January 27, 2023, for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 

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Vios Fertility Institute – St. Louis and TMRW Life Sciences Launches State-of-the-Art Cryo Management Technology for Fertility Specimens

TMRW’s technology provides the world’s first and only fully automated specimen management platform (CryoRobot) that identifies, tracks, and manages frozen eggs and embryos – central to almost every IVF journey.  Vios Fertility Institute’s Chicago lab was the first in the world to adopt this revolutionary technology in early 2021.  

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