Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other steps to determine if...
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.
FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.
