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-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-

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.

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.

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

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.

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.

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.

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).