A comprehensive view of Approved Drugs/Devices. This page highlights a small sample of our full coverage.
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Recent Articles

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FDA approves Bayer’s oral Nubeqa along with chemotherapy docetaxel and androgen deprivation therapy to treat metastatic hormone-sensitive prostate cancer; Bayer projects peak sales of Nubeqa of between US$1.1B to US$3.4B

Biovica’s DiviTum TKa assay that detects biomarker in blood to monitor breast cancer progression in metastatic postmenopausal females receives FDA 510(k) clearance; Biovica to launch product in US before end of 2022

Twist Bioscience, Biotia receive expanded emergency use authorization from FDA for their SARS-CoV-2 Next-Generation Sequencing assay; assay detects, identifies, differentiates SARS-CoV-2 lineages, specific genomic mutations

Regeneron reports Q2 GAAP net income down 73% from a year ago to US$852M, with revenues down 44% year-over-year to US$2.86B; Q2 saw record sales of EYLEA, Libtayo and Dupixent, which FDA approved to treat atopic dermatitis and eosinophilic esophagitis

FDA gives 501(k) clearance to Onkos Surgical’s My3D patient-specific pelvic reconstruction 3D printed implants, instruments, models to treat pelvic trauma, deformity, disease; implants for acetabular, advanced reconstruction in multiple pelvic regions

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