Market Access The EU Joint Clinical Assessment in practice: Early lessons Unfortunately, much of the discussion around the JCA has focused on how the framework is intended to operate, rather than how it works in practice.
Market Access Navigating Europe's AI regulatory labyrinth: A strategic gui... For US drug developers, bringing AI tools across the Atlantic introduces steep regulatory hurdles.
News EU warns of brain tumour risk with some contraceptives EU pharmaceutical safety advisers have said that commonly used contraceptives may carry a small risk of a type of brain cancer with prolonged use.
News Bayer's asundexian starts EU review for ischaemic stroke The EMA has started its review of Bayer's asundexian for secondary stroke prevention, keeping it ahead of a rival drug from BMS and J&J.
News Oral Wegovy backed by CHMP at May meeting The CHMP recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral weight loss therapy.
News EMA seeks input on virtual alternative to animal test EMA delivers a milestone in the replacement of animals in drug testing with the qualification of a virtual model for repeat-dose toxicity studies.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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