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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...[ Price : $8.95]
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.[ Price : $8.95]
FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.