A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital marketing identifies several cross-cutting themes...
FDA and Instem researchers say 92% of Medical Device Reports filed between 2011 and 2021 involved device issues rather than patient adverse events.
Pfizer plans to share with FDA favorable data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with...
Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets as an adjunct to ins...
Acadia Pharmaceuticals stops developing pimavanserin for treating negative symptoms of schizophrenia based on disappointing top-line results from a Ph...
Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment.
Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologics.
Federal Register proposed rule: FDA proposes to revise the requirements for the content and format of labeling for approved or conditionally approved ...
