Section
Drug pipelines, trials, and biotech investment.
The US approval of Fayuvi marks a historic moment for a devastating childhood condition with no previously licensed treatment.
Oveporexton's US approval sets the clock running on a potential MHRA review and NHS access debate for a condition with few good options.
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 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.