Topic dossier
FDA, MHRA, EMA and the rules shaping healthcare markets.
Europe's medicines regulator has launched a phased review of daraxonrasib, raising hopes for a disease with few effective treatments.
New EMA initiatives aim to close persistent gaps in how medicines are developed and regulated for female patients.
A US generic approval for the single-dose flu drug baloxavir marboxil raises questions about access, pricing, and NHS formulary strategy.
The Emergency Use Listing marks a first for BDBV diagnostics, with implications for global outbreak preparedness and UK biosecurity planning.
The EMA's human medicines committee recommended six new treatments and two biosimilars at its latest monthly meeting.
A supplemental US approval for the CRISPR-based therapy Casgevy broadens its eligible population — with significant implications for UK commissioning.
A new briefing reveals the hidden workforce cost of mandating A&G as a substitute for hospital referrals.