Development Genotoxicity Genotype Production 
The Pharma Data
MARCH 25, 2021
The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation. SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Embryo-Fetal Toxicity.
The Pharma Data
APRIL 7, 2021
Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.
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