The European Medicines Agency has chosen 23 speakers from 55 requests made by people interested in sharing their experiences with the use of these widely-prescribed antibiotics.
The European Medicines Agency's second ever public hearing under the EU pharmacovigilance legislation – on the long-lasting side-effects of quinolone and fluoroquinolone antibiotics – has drawn a lot of interest from stakeholders who want to share their experiences at the event on June 13.
A total of 115 requests were submitted for participation at the hearing – 55 speakers and 60 observers. Regarding the...
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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