There is a new drug safety issue for Stelara. This time it is that Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara. The Stelara French study results were outlined in this medical journal … More
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Recent Articles
Black Box Warning Label Change for Breast Implants Finalized by the FDA
Since our previous article, “New BIA-ALCL Cases Identified in Updated FDA Report“, the FDA has finalized labeling guidance for breast implant manufacturers. The FDA label change is now requiring a black box label warning for the breast implant devices. In recent years, many textured breast implants … More
Biomarker candidates could aid in earlier diagnosis of mesothelioma
Mesothelioma is a deadly cancer mainly caused by exposure to asbestos fibers. Unfortunately, mesothelioma is generally diagnosed at an already advanced stage and none of the therapeutic strategies tried so far is able to eradicate the disease. So new biomarkers that could help to identify the … More
Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation
In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA … More
A multicentre randomised phase III trial comparing pembrolizumab vs single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial
Background: Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterized by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have … More
Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020
In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. It seems a possible Ocaliva liver-related side effects risk has attracted scrutiny, and there is an Ocaliva liver safety FDA evaluation … More