Drug Approval | March 22, 2022
Merck’s Keytruda approved for fourth gynecologic cancer indication
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
Under the agreement, Lonza will deliver cGMP-standard drug substance for clinical supply
At the interim analysis, the combination of Keytruda and Lynparza did not demonstrate a benefit in overall survival (OS), one of the study’s dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide
First PARP inhibitor to demonstrate overall survival benefit in early breast cancer
The investment will accelerate the overall Sarclisa development program
Guardant360 CDx is a comprehensive genomic profiling test that utilizes blood samples from patients with advanced solid cancers
In numerous neurological and rare disorders, where clinical characteristics can be confusing, NGS-based approaches have demonstrated considerable increases in disease detection rates over other approaches
Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial
The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts
Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder
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