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TXT Glaxo NDA Accepted for Anemia Drug [216 Words] [ Price : $8.95]
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.
04/21/2022
 
 
TXT Panel Recommends Randomized Trials for PI3K Inhibitors [407 Words] [ Price : $8.95]
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.
04/21/2022
 
 
TXT FDA Wants Comments on Opioid Disposal Proposal [2704 Words] [ Price : $8.95]
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.
04/20/2022
 
 
TXT AbbVie Abandons Alpha-Synuclein Parkinson’s Program [204 Words] [ Price : $8.95]
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.
04/20/2022
 
 
TXT Device Resilient Supply Chain Workshop Scheduled [2756 Words] [ Price : $8.95]
FDA launches a medical device resilient supply chain program and schedules a virtual public workshop on the effort.
04/20/2022
 
 
TXT FDA Drug ‘Recall-Ready’ Tips [2698 Words] [ Price : $8.95]
A CDER podcast gives drug companies steps to follow to be better able to handle recalls quickly and efficiently.
04/20/2022
 
 
TXT 2019 NARMS Integrated Summary Out [2694 Words] [ Price : $8.95]
FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in humans remained steady.
04/20/2022
 
 
TXT American Regent Production Supervisor Sentenced [2662 Words] [ Price : $8.95]
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.
04/20/2022
 
 
TXT Study on Physician Use of Off-label ‘Unsupportive Data’ [428 Words] [ Price : $8.95]
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.
04/20/2022
 
 
TXT FDA Needs Procedures for Reporting Political Interference: GAO [678 Words] [ Price : $8.95]
A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations of political interference.
04/20/2022
 
 
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