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M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines (published 04-Mar-2026) Download FDA Guidance E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (published 04-Mar-2026) Download FDA Guidance Questions and Answers on Biosimilar Development and the BPCI Act (published 08-Mar-2026) Download FDA Guidance Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (published 09-Mar-2026) Draft FDA Guidance New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) (published 09-Mar-2026) Draft FDA Guidance General Considerations for the Use of New Approach Methodologies in Drug Development (published 19-Mar-2026) Draft FDA Guidance Approval Date: 03/06/2026 Drug Name: PYLARIFY TRUVUNDA #220089 Active Ingredients: PIFLUFOLASTAT F-18 Submission Classification*: Type 5 - New Formulation or New Manufacturer Review Priority**: Standard Company: APHELION Approval Date: 03/17/2026 Drug Name: ICOTYDENDA #220149 Active Ingredients: ICOTROKINRA HYDROCHLORIDE Submission Classification*: Type 1 - New Molecular Entity Review Priority**: Priority Company: JANSSEN BIOTECH Approval Date: 03/17/2026 Drug Name: LYNAVOYNDA #220295 Active Ingredients: LINERIXIBAT Submission Classification*: Type 1 - New Molecular Entity Review Priority**: Standard Company: GLAXOSMITHKLINE Approval Date: 03/19/2026 Drug Name: FLAVALTANDA #216564 Active Ingredients: EPINEPHRINE BITARTRATE

The tumor volume was calculated by measuring the perpendicular diameter of the tumor using calipers and calculated according to the formula: Orthotopic liver cancer mouse model Luciferase reporter HepG2 (HepG2-Luc) cells (1 10 5 ) were intraportal injected into the livers of nude mice
Back and coworkers reported that spirodioxyselenurane and its tellurium analog exhibit very efficient GPx-mimicking activity (Back et al