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The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
SAN DIEGO and ZUG, Switzerland, Jan. 10, 2024 /PRNewswire/ -- Mirati Therapeutics, Inc.® , a commercial stage biotechnology company, today announced that the European Commission granted...
STADA and Alvotech’s Uzpruvo gained an EU marketing authorisation, allowing it to be sold in the European Economic Area in 2024.
The European Commission has granted conditional marketing authorization to adagrasib for use in adult patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation whose disease progressed following at least 1 prior systemic treatment.
Received 459 new patient start forms for FILSPARI® in the fourth quarter of 2023; preliminary net product sales of FILSPARI totaled $15 million for the fourth quarter Company on track to submit...