List view / Grid view
US Food and Drug Administration (FDA)
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Most therapeutic approaches in immuno-oncology focus on targeting the adaptive immune system; innate immunity has only recently gathered momentum. One of the most potent receptors for activating innate immune cells such as natural killer cells and macrophages is CD16A. Addressing this target mimics the body’s natural defense against potential threats,…
Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
Novartis’ Vijoice® (alpelisib) is the first and only treatment approved for the treatment of the rare spectrum of conditions associated with PROS in certain patients.
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
The results of Eli Lilly and Company’s double-blind, placebo-controlled Phase III trials for Olumiant® are encouraging for patients suffering with alopecia.
Novartis has received a boost to its arsenal of cancer therapeutics after the FDA approved Pluvicto™ and complementary diagnostic imaging agent Locametz® to treat advanced prostate cancer.
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
Investigational drug Lambda reduced risk of COVID-19-related death in one of the largest studies of its kind to date.
AbbVie releases promising results from its Phase III trial of atogepant (Qulipta™) for preventative treatment of chronic migraine.
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).