Phathom Pharmaceuticals resubmits its NDA for vonoprazan tablets to treat erosive gastroesophageal reflux disease, responding to a complete response l...
FDA approves a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVies blockbuster Humira.
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for the Collection of Qualitative Feedba...
FDA publishes a draft guidance on using generally accepted scientific knowledge in drug and biological product applications.
FDA extends by three weeks its review of a Sarepta Therapeutics BLA for SRP-9001 (delandistrogene moxeparvovec), a gene therapy product for treating a...
FDA publishes a Q&A guidance on using and managing whole slide images used during histopathology assessment and/or pathology peer review.
FDA asks for answers to several questions about factors that should be considered in requests from sponsors of drugs subject to REMS related to change...
The International Council for Harmonization releases for public comment a draft document entitled ICH Harmonized Guideline Good Clinical Practice (GC...
