The V114 vaccine candidate consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease.
The FDA is alerting clinical laboratory staff and health care providers regarding the risk of false negative results with any SARS-CoV-2 test if a mutation occurs in the part of the virus’ genome assessed by that test.
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and blocking its interaction with the poliovirus receptor.
The test should be utilized in accordance with its Emergency Use Authorization and as described in the authorized labeling to reduce the risk of false negative results.
In 2018, the FDA granted accelerated approval to Opdivo for SCLC based on data from the phase 1/2 CheckMate -032 trial.
The sNDA is supported by data from the phase 3 CROWN study comparing lorlatinib to Xalkori in 296 adults with advanced ALK-positive NSCLC.
The vaccine candidate contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses.
The full list of CFTR gene mutations for Trikafta, Symdeko and Kalydeco can be found in the updated prescribing information for each respective product.
The approval was based on data from the double-blind, placebo-controlled phase 3 ADAURA study.