Europe Restricts Cyproterone Use Due To Meningioma Risk; Companies To Conduct Studies
The risk of developing meningioma with cyproterone-containing medicines is rare, but it is serious enough to merit restrictions on how such products are used, according to the European Medicines Agency.
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The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include a new product – Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.
Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.