Tag: EMA
Only 29% of FDA orphan drug approvals receive matching EMA authorisation
A 13-year analysis of 814 FDA orphan drug approvals found that only 29% received matching EMA authorisation with orphan status,…
Hormonal Contraceptives With Progestogen Linked to Slightly Elevated Meningioma Risk
A 25-year Danish register study linked progestogen-containing oral contraceptives to a modestly elevated meningioma risk. The Danish Medicines Agency has…
EMA Launches Email Notifications for Clinical Trial Information System
The European Medicines Agency has rolled out email notification subscriptions in CTIS, enabling clinical trial sponsors and researchers to receive…
European Medicines Agency Withdraws Levamisole Drugs Over Severe Neurological Risks
European Medicines Agency withdraws all levamisole medicines from EU markets due to serious neurological risks identified by safety committee. Nigerian…
EU and US Drug Regulators Split Over AstraZeneca’s New Breast Cancer Treatment
European and American drug regulators reached opposing conclusions on AstraZeneca's experimental breast cancer treatment. The EMA endorsed the antibody-drug conjugate…
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