Roche RHHBY announced that the European Commission (EC) approved PiaSky (crovalimab) for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). PiaSky is a novel recycling ...

PNH was once a rare disease with no approved therapeutic options. The market for PNH drugs is now growing crowded. Soliris’s 2007 approval made it the first therapy for the disorder.

Credit: Novartis. The approval was based on data from the phase 3 APPLY-PNH trial. Health care providers who prescribe Fabhalta must enroll in the Fabhalta REMS. The Food and Drug Administration ...

Subcutaneous C5 Inhibitor Approved for PNH — Longer-acting crovalimab designed for more sustained effect and less treatment burden by Ian Ingram , Managing Editor, MedPage Today June 24, 2024 ...

If approved, crovalimab would be the first PNH drug that could be given by subcutaneous injection once a month outside a supervised healthcare setting, setting up a challenge to AstraZeneca's ...

The Paroxysmal Nocturnal Hemoglobinuria treatment market is experiencing significant expansion, driven by increasing disease awareness, rising preval ...

The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted ...

Reports DescriptionAccording to the analysis conducted by Custom Market Insights (CMI), the Ultomiris drug market is ...

Apellis Pharmaceuticals’ APLS shares gained 3.2% on Tuesday following the announcement of a capped royalty deal with Sobi, under which Apellis will receive up to $300 million in return for 90% of its ...

[This] news means our… national PNH service now has access to the first oral treatment option for this rare disease.” Fabhalta was approved by the US Food and Drug Administration (FDA) for adults with ...