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Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe
Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…
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Rigel has reported the availability of Veppanu (vepdegestrant) by prescription in the US for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following ≥1L of endocrine therapy
Veppanu (200mg, PO, QD) is an FDA-approved PROTAC, a class of targeted protein degraders that uses the body’s natural machinery to…
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Myriad Genetics has commercially launched FirstGene Multiple Prenatal Screen, combining four prenatal genetic screens in a single blood draw as early as 8wks. gestation
FirstGene covers common chromosomal conditions, 19 recessive fetal conditions, 20 maternal carrier conditions, & fetal RhD status, with >98% analytical sensitivity & >99% specificity, and results available in ~10 days;…
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Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US
Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025
Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…
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Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products
Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty
Denosumab is a mAb that works…
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Bausch + Lomb has launched Bi-Blade+ advanced dual-port vitrectomy cutter on the Stellaris Elite Vision Enhancement System in the EU for anterior & posterior segment procedures requiring vitreous removal
Bi-Blade+ delivers a 25% higher flow rate for more efficient vitreous removal compared to Bi-Blade & demonstrated a 62% reduction in cutter vibration, aimed at…
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Ortho Development has reported the full US commercial launch of the Trivicta Hip Stem, a cementless triple-taper femoral component for primary total hip arthroplasty, following a controlled market introduction
Trivicta system features a 35μm hydroxyapatite coating over sintered titanium beads to support early osteointegration, alongside standard & extended offset options, progressive neck lengths, &…
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Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026
The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…
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restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency
Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…
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Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US
The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…

