Several questions about the anti-amyloid product used to treat Alzheimer’s remain, which could affirm calls for more US FDA, CMS and NIH collaboration on research.
Even with apparent indicators of efficacy, clinicians still have questions about using Biogen, Inc. and Eisai Co., Ltd.’s Leqembi (lecanimab-irmb) in Alzheimer’s disease patients. Many likely require more study and some could be limiting uptake.
Leqembi has no guidance on when treatment should end, Erik Musiek, an associate neurology professor at Washington University School of Medicine, said during a Health and Human Services Department Advisory...
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
