GenBioPro, which markets a generic version of the medical abortion product, may pursue litigation in a more favorable jurisdiction than the Mississippi district court where the case had been proceeding. Senators ask HHS to consider filing its own suit to enforce federal preemption of state laws, lifting REMS restrictions and having FDA issue an EUA for misoprostol.
A legal ruling on whether US Food and Drug Administration policy preempts state laws restricting access to medication abortion has been delayed with GenBioPro Inc.’s decision to drop its suit challenging Mississippi’s laws.
GenBioPro filed a notice with the US District Court for the Southern District of Mississippi on 18 August that it...
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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