Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently […]readmore
Tags : U.S.FDA
Shots: The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a […]readmore
Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL […]readmore
Biotech
Regulatory
Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s
Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for […]readmore
Shots: Abbott has received the US FDA’s EUA for AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the ARCHITECT and Alinity platforms Till now, Abbott has received EUA for […]readmore