Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibra...
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...
Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning...
Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.
FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healthcare providers, and industry.
FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unre...
