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Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attr...[ Price : $8.95]
A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug efficacy when clinical trial resul...[ Price : $8.95]
FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy...[ Price : $8.95]
FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.[ Price : $8.95]
FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.[ Price : $8.95]
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...[ Price : $8.95]
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about...