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New Drug Approval Trends (2015-2024) by FDA, EMA, PMDA & Other Agencies Market Trend Trends in new drug approvals from 2015-2024 by six major regulatory agencies including FDA, EMA, PMDA, highlighting approval numbers, timelines, accelerated pathways, and patient experience data integration.
EU Confirms Vision Risk Tied to Semaglutide EMA EU regulators have confirmed a rare risk of vision loss linked to Novo Nordisk’s semaglutide, used in Wegovy and Ozempic. Drug labels will be updated to reflect the potential for NAION, a serious but very rare eye condition.
Arsenic Trioxide for Leukemia Treatment Arsenic Trioxide Hong Kong researchers developed ARSENOL?, the first oral arsenic trioxide drug for APL treatment, achieving over 97% survival. Approved by FDA & EMA, it's set to revolutionize leukemia care globally.
The Legendary Liver Disease Drug Descends from the Pedestal FDA Ocaliva (Obeticholic acid), a once-promising liver disease drug, faces setbacks in both the US and Europe. After failing to secure MASH approval and with declining sales, its future remains uncertain.
EMA Takes Action on Metamizole-Induced Risks EMA The EMA has issued new recommendations to mitigate agranulocytosis risks associated with metamizole, urging increased awareness among healthcare providers and patients. Symptoms include fever and sore throat; immediate medical attention is crucial.
CHMP July 2024 Meeting: 14 New Medicines Recommended EMA CHMP's July 2024 meeting recommended 14 new medicines and 11 indication expansions. Highlights include new treatments for eczema, liver disease, and cancer, plus six biosimilars and one generic.
EMA Approves First Nasal Spray for Anaphylaxis EMA Discover Eurneffy, the first nasal spray recommended by the EMA for anaphylaxis treatment. Learn about its needle-free convenience and clinical effectiveness in severe allergic reactions.
EMA's CHMP June 2024 Approvals and Recommendations EMA In June 2024, the EMA's CHMP recommended 10 new medicines for approval, including Balversa for urothelial carcinoma and Eurneffy, the first nasal spray for allergic reactions. Notable approvals also include mResvia, an mRNA vaccine for RSV, and treatments for various cancers and rare diseases.
EMA Initiates Review of Painkiller Metamizole EMA EMA launches review of metamizole medications due to agranulocytosis risk concerns. Learn about the review process, reasons, and potential impact on EU authorizations.
EMA Recommends Trivalent Vaccines for 2024 Influenza Season EU The EMA recommends shifting from quadrivalent to trivalent influenza vaccines for 2024, excluding the B/Yamagata strain. New guidelines aim to boost seasonal flu vaccine effectiveness.

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