Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an...
A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug efficacy when clinical trial results are mixed, using ...
FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance...
FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.
The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.
JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...
