Phase III data presented at ASH impress clincians, hopeful for a change in standard of care.
The first Phase III data for Novartis AG's acute myeloid leukemia (AML) therapy midostaurin have hematologists excited as the drug "inches forward" towards a market approval – opening up the door for possible evolution of standard of care for AML patients, which has been sealed shut for the past 30 years.
Novartis reported Phase III midostaurin data from its RATIFY trial in newly diagnosed, FLT3-mutated AML patients under the age of...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.
