FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three categories on the lists.
Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential gener...
Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical gas helium because th...
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Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation program.
