FDA Issues Guidelines for Regulating Health Artificial Intelligence
The FDA provided new guidance on the regulation of mobile health software and clinical decision support (CDS) tools that use artificial intelligence (AI). The...
Democrats and Republicans Unveil Competing Drug Pricing Bills
Lowering drug costs is a major bipartisan voter issue, but tensions between parties have been escalating as Democrats introduced a bill that would allow...
FDA Approves Daratumumab-Based Quadruplet Regimen for Transplant-Eligible Myeloma
The U.S. Food and Drug Administration (FDA) approved the quadruplet regimen consisting of daratumumab, bortezomib, thalidomide, and dexamethasone to treat adult patients with newly...
NSTC Developing New Plans to Reduce Foreign Influence on U.S. Research
Co-chair of the National Science and Technology Council (NSTC) Kelvin Droegemeier, PhD, is developing new requirements for what information researchers must disclose to receive...
Opioid Manufacturers Reach Settlements in State Lawsuits
Large drug manufacturer Purdue Pharma has agreed to pay $10 billion to settle more than 2,600 lawsuits filed by states, cities, counties, individuals, and...
FDA Places Trials of MCL-1 Inhibitor on Clinical Hold
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on a phase I, dose-escalation study of AMG 397, an oral, small...
FDA Approves Ferric Maltol for Treatment of Iron Deficiency
The U.S. Food and Drug Administration (FDA) announced its approval of oral ferric maltol for the treatment of iron deficiency in adults.
Ferric maltol is...
Rivipansel Fails to Meet Phase III Trial Endpoints
In a pivotal phase III trial, rivipansel failed to meet its primary and secondary efficacy endpoints in patients with sickle cell disease (SCD) who...
Genetic Testing and Drug Companies Partner to Develop New Medicines
Since its launch, 23andMe has provided more than 8 million customers with information about their ancestry and predisposition to developing certain diseases. Now, a...
Insurers Propose Coverage of Expensive Gene Therapies
Large health insurers have unveiled new payment models to make gene therapies – which offer a one-time cure for patients with life-threatening and rare...
Current Issue
November 2019 Bonus ASH Annual Meeting Preview Edition (Volume 5, Issue...
This issue offers an inside look at this year’s annual meeting, advice for giving effective presentations, and more.
