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.
FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in humans remained ste...