The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.
Women with liver problems should not take Gedeon Richter PLC’s uterine fibroid treatment Esmya (ulipristal acetate) because the product may have contributed to the development of some cases of serious liver injury. In addition, liver function tests must be carried out before patients are started on a treatment course with the product.
These are two of the recommendations made by the European Medicines Agency’s pharmacogivilance risk assessment committee (PRAC) at its...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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