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Press Releases
Izotropic Featured in Announcement of Research and Markets’ U.S. Breast Cancer Analysis and Forecast
- Company listed in Research and Markets’ announcement and description of new research report on the U.S. Breast Cancer Screening and Diagnostic Market- - “U.S. breast cancer screening and diagnostic [device] market was valued at $1.55 billion in 2024 and is anticipated to reach $2.34 billion by the end of 2030, at a CAGR of 7.05% during the forecast period 2024-20301"- -Report supports Company’s regulatory strategy for IzoView Breast CT, reinforces high demand for new breast imaging modalities, strengthens the potential for rapid market adoption and significant market share -
January 17, 2025
·
8 min read
Press Releases
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
March 3, 2025
·
6 min read
Press Releases
CTT Pharma Gives Update On U.S. and European Patents
February 25, 2025
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1 min read
Press Releases
The U.S. FDA Grants Fast Track Designation to Coherent Biopharma’s CBP-1019
February 24, 2025
·
1 min read
Press Releases
Izotropic Files Pre-Submission with U.S. FDA for Breast Cancer Screening
-A screening indication for women with dense breast tissue adjunctive to 3D mammography increases the market size for annual IzoView scans by over 800%1 for initial approval and product launch- -Regulatory strategy responds to the “urgent call2" from the U.S. Preventative Services Task Force for solutions to finding breast cancers earlier in women with dense breast tissue- -Comprehensive filing includes patient acquisition and clinical study plans that validate a projected clinical study timeline of 2.5 years with an approximate cost of USD 3.5 million-
January 9, 2025
·
15 min read
Brain Navi Announces 100th Surgical Procedure Completed Using NaoTrac
Brain Navi announced the completion of the 100th case utilizing its neurosurgical navigation robot NaoTrac.
January 15, 2024
·
3 min read
Manufacturing
Lilly Puts $27B Into U.S. Manufacturing Bump Following Trump’s Tariff Threats
The move comes after President Donald Trump warned Big Pharma leaders that he would impose tariffs on them if they refuse to reshore their manufacturing operations.
February 27, 2025
·
2 min read
·
Tristan Manalac
BIOSECURE Act
WuXi Biologics Faces Uncertain Future in the U.S. After BIOSECURE Blow
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma.
October 8, 2024
·
5 min read
·
Ben Hargreaves
Press Releases
Cellino Launches U.S.’s First Nebula-Powered iPSC Foundry for Scalable Autologous Biomanufacturing
February 24, 2025
·
2 min read
Press Releases
Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil
February 20, 2025
·
5 min read
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