FDA Approves Hameln’s Radiation Exposure Therapies
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency encouraged NDA filings for Ca-DTPA and Zn-DTPA in a September 2003 guidance. The drugs are used to treat internal contamination with plutonium, americium or curium.
You may also be interested in...
NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter
Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials
Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products
Acomplia’s Large European Cash Market Not Affecting Dropout Rate – Sanofi
A substantial portion of European patients purchasing Sanofi-Aventis' Acomplia pay entirely out-of-pocket for the obesity drug