Regulatory

The company said the FDA placed the hold on RGX-111 and RGX-121 after a patient in its RGX-111 trials developed a brain tumor, the cause of which remains under investigation.

The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.

Generics Bulletin reviews global regulatory developments across the world.

Brazil’s new drug pricing rules, which come into force in April, are intended to better recognize incremental innovation and give more predictability to the pricing of biosimilars.

The UK MHRA will soon consult on allowing CE-marked devices indefinite access to the Great Britain market. Meanwhile, the EU has at last moved to make the MDR/IVDR more user friendly. Taylor Wessing partner Alison Dennis reflects on how these events could influence evolving UK medtech legislation.

The firm's type 1 diabetes drug has been given the green light by the European Commission.

The Swiss biotech’s shares jumped by 27% after the US agency said another trial was not needed to submit sonelokimab.

The European Commission sees the value of biosimilars, but its biotech vision lacks competitive incentives to build on the region’s relevance.

The European Commission sees the value of biosimilars, but its biotech vision lacks competitive incentives to build on the region’s relevance.

Generics Bulletin reviews the first year of Trump 2.0 and its impact on the off-patent sector, which was marked by both favorable and less beneficial movements by US president Donald Trump and his administration.

Catch up on the developments released in the last days of 2025, from year-end FDA approvals, complete response letters and several trial disappointments.