This page shows the latest black box warning news and features for those working in and with pharma, biotech and healthcare.
In 2019, the FDA released a formal warning in response to initial results that showed an increased risk of blood clots and death with the higher dose. ... At that time, the US drugs regulator issued a black box warning to the prescribing information for
BMS, Novartis and Gilead/Kite’s respective CAR T therapies all carry a black box warning for neurotoxicity, as well as cytokine release syndrome – an overreaction of the body’s immune
Although this could lead to a potential black-box warning on the label if the drug is approved, the benefit of a 60.9% response in patients who have already been
Some analysts have predicted that Inrebic could also become a $1bn product in myelofibrosis, despite a black-box warning on its label for a serious and life-threatening brain reaction called
Some analysts think Inrebic could become a $1bn product for myelofibrosis, despite a black-box warning on its label for a serious and life-threatening brain reaction – Wernicke's encephalopathy – that
2016 before the addition of a black-box warning to its label in 2017.
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