President Biden meets with potential FDA commissioner nominee Robert Califf in what may be the last step before an official announcement.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Orion Corp.s Nubeqa (darolutamide).
Federal Register notice: FDA seeks comments on an information collection extension entitled PHS Guideline on Infectious Disease Issues in Xenotranspla...
FDA denies an Informed Consent Action Network petition asking it to revoke the EUAs for the Moderna and J&J Covid vaccines.
FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data.
FDA expands its Covid-19 regulatory science work with Aetion.
FDA gives de novo premarket approval to Luminopia One to use a virtual reality headset to treat amblyopia, or lazy eye, in children ages 4-7.
FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one patient.