FDA accepts a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia related to chronic kidney disease.
An FDA advisory panel unanimously votes to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors be supported by randomized clinical trial data.
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 analgesics.
AbbVie walks away from a partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805 — a humanized monoclonal antibody targeting alpha-synuclein being investigated for treating Parkinson’s Disease.
FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in humans remained steady.
The Justice Department says an American Regent drug production supervisor has been sentenced to jail time and payment of restitution for stealing thousands of bottles of an equine drug.
A new study about the influence of data disclosures on physician decisions about off-label uses suggests that there is limited awareness of, and exposure to, unsupportive data about off-label uses among physicians.
A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations of political interference.