FDA issues a finalized guidance on developing human drug products that contain nanomaterials.
FDA accepts a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia rel...
An FDA advisory panel unanimously votes to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors be su...
The National Evaluation System for Health Technology Coordinating Center is partnering with Aetion on a five-year strategic effort to advance the use ...
FDA solicits comments on a proposal to change the opioid REMS to provide postage-paid mail-back envelopes patients can use to return unused opioid ana...
AbbVie walks away from a partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805 a humanized monocl...
FDA launches a medical device resilient supply chain program and schedules a virtual public workshop on the effort.
A CDER podcast gives drug companies steps to follow to be better able to handle recalls quickly and efficiently.