FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an investigational drug...
FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with newly diagnosed Philade...
FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating ...
A bipartisan group of nine senators asks the Defense Department for an update on its efforts to secure the military pharmaceutical supply chain.
Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation program.
FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the companys BLA for pz-ce...
FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.
Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guidance entitled Early Alzheimers Disease: Developing ...
