The Swiss biotech has got the thumbs up in the US for its insomnia drug which will be sold as Quviviq and is expected to be provide serious competition for Merck & Co's rival dual orexin receptor antagonist Belsomra.

The US biotech has presented interesting preliminary data from the first four patients treated in the Phase I/II STAAR study evaluating isaralgagene civaparvovec for Fabry.

A mix of equity and debt financing has raised enough to satisfy Santhera's liquidity needs until mid-2022, which will be after the Swiss firm has filed its Duchenne drug vamorolone.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.