PhRMA and BIO praise FDA efforts to use digital health technology in drug and biologic regulatory decisions.
Federal Register notice: FDA announces a 6/28 advisory committee meeting to discuss an Ipsen Biopharmaceuticals NDA for palovarotene capsules.
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FDA publishes a draft guidance on using generally accepted scientific knowledge in drug and biological product applications.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.
