Treats paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. Sold as Piasky. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Crovalimab-Akkz (sold as Piasky), first approved Jun 20, 2024, with 0 new uses approved and 0 published complete response letters.
| Program | Updated |
|---|---|
| Piasky REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled | May 29, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 20, 2024 | PiaskyBLA 761388 · New molecular entity | Genentech Inc | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
