Mixed Opinions on Quizartinib From the FDA and Japanese Regulators
After the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee decided against recommending approval of quizartinib for patients with relapsed/refractory FLT3-ITD acute...
FDA Approves First Anticoagulant for Pediatric Patients
The FDA approved dalteparin sodium, administered as a subcutaneous injection, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients (≥1 month).
Dalteparin...
Trump Administration Ends Fetal Tissue Research at NIH
In June, the Department of Health and Human Services (HHS) announced a new policy curtailing government-funded research that uses fetal tissue donated after elective...
FDA Recalls Three Hematology Analyzers
The FDA issued a Class I recall of three hematology analyzers – Beckman Coulter DxH 800, DxH 600, and DxH 900 – after reports...
FDA to Close Its Controversial Medical Device Reporting Program
In what is being called a victory for patients and consumers, the U.S. Food and Drug Administration (FDA) said that it is ending its...
FDA Expands Ivosidenib’s Indication to Newly Diagnosed AML
On May 2, 2019, The U.S. Food and Drug Administration (FDA) approved an expanded indication for the IDH1 inhibitor ivosidenib to include the treatment...
Federal Trade Commission Wins Case Against Predatory Publisher
OMICS International, which publishes nearly 700 scientific journals, was ordered to pay $50.1 million in damages for engaging in “predatory publisher” tactics. The ruling...
Europe Poised to Approve Gene Therapy for Beta Thalassemia
Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended that the European Medicines Agency (EMA) approve Bluebird Bio’s LentiGlobin gene-therapy product for patients...
U.S. CRISPR Study in Humans Gets Underway
The first patients enrolled in a trial of CRISPR-based gene editing at the University of Pennsylvania have been treated with the powerful – and...
FDA and State Authorities Renew Efforts Against Dangerous Stem Cell Clinics
The U.S. Food and Drug Administration (FDA) and New York’s attorney general have announced new policing strategies against for-profit clinics that offer expensive and...
Current Issue
July 2019 Bonus Mid-Year Edition, Volume 5, Issue 9
This issue features a look at research espionage, coverage from the ASCO and EHA annual meetings, and more.
