In cooperation with the Food and Drug Administration (FDA), and as a service to our members, we will periodically distribute information about newly approved therapies or significant changes to approved therapies. This helps FDA to inform professionals in patient care arena of recent approvals in a timely manner. Included in the email from the FDA is a link to the product label, which will provide the relevant clinical pharmacology information on the indication, contraindications, dosing, and safety. In sending this information, we do not endorse any product or therapy and do not take any position on the safety or efficacy of the product or therapy described.
FDA Announces Availability of Two Final Guidances, Clinical and In Vitro Drug Interaction Studies -- Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions
FDA Approves AYVAKIT (Avapritinib) for the Treatment of Adults with Unresectable or Metastatic Gastrointestinal Stromal Tumor Harboring a Platelet-derived Growth Factor Receptor Alpha Exon 18 Mutation
2019 FDA Bursts
2018 FDA Bursts
2017 FDA Bursts
2016 FDA Bursts