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694,411 Results for "amplifon s p a us headquarters".
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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
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
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5 min read
·
Ben Hargreaves
Business
EMD Serono Announces Plans for New U.S. Healthcare Headquarters in Boston’s Seaport District
EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced that it plans to move its U.S. Healthcare headquarters, currently located in Rockland, Mass., to Boston’s Seaport district.
November 14, 2023
·
3 min read
Press Releases
Adaptimmune Announces U.S. FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS)
The Company will present at the Annual J.P. Morgan Healthcare Conference, providing business updates on its sarcoma franchise and other cell therapy pipeline assets Adaptimmune Allo-T program to be featured at the Biotech ShowCase(TM) and the Wuxi Global Forum 2025
January 13, 2025
·
5 min read
Press Releases
David P. King Joins Truvian’s Advisory Board
January 13, 2025
·
2 min read
FDA
2024 Ends With Greenlights for Merck’s PAH Drug in UK and BMS’ Opdivo Injection in US
Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
January 2, 2025
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2 min read
·
Kate Goodwin
Regulatory
Novo Secures EU Panel’s Backing for Cardiovascular Use of Wegovy
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
September 20, 2024
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2 min read
·
Tristan Manalac
Press Releases
Cresilon Announces U.S. Nationwide Launch of TRAUMAGEL
January 14, 2025
·
4 min read
Business
Complete Genomics opens U.S. supply chain to genomic sequencing customers through a new manufacturing facility at its San Jose, Calif. headquarters
Complete Genomics, a pioneering genomic sequencing company, recently welcomed vendors, suppliers, customers and employees to a May 17 grand opening celebration of its 10,115 square foot manufacturing facility at its headquarters in San Jose, California.
May 23, 2024
·
2 min read
FDA
Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer’s Disease
Quanterix Corporation announced today that its Simoa ® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s Disease (AD).
March 4, 2024
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4 min read
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