The European Medicines Agency has completed its investigation into the safety of nomegestrol and chlormadinone, and has started reviewing risks linked to the cough suppressant, pholcodine, and the epilepsy and migraine drug, topiramate.
Restrictions are to be placed on the use of drugs containing high doses of nomegestrol or chlormadinone in the EU after the European Medicines Agency concluded that these medicines, which are used to treat gynecological disorders, can increase the risk of meningioma.
In addition, the EMA has started an urgent review of the safety of the cough suppressant, pholcodine, as well as...
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
