Quick answers
- What is Crovalimab used for?
- The FDA-approved label (Piasky, Genentech, Inc., November 11, 2025) says: “PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. PIASKY is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Crovalimab have a boxed warning?
- Yes. The FDA label for Piasky has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Crovalimab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Crovalimab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Crovalimab?
- 1 company lists prescription products of Crovalimab in the FDA NDC Directory, including Genentech, Inc..
What Crovalimab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. PIASKY is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg
— FDA label: Piasky, Genentech, Inc., effective November 11, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Piasky |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genentech, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761388 PIASKY | Genentech Inc | June 20, 2024 | 1, latest May 14, 2025 2025: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2686626, 2686633 |
|---|---|
| SPL set ID of the quoted label | 2597efc2-a97b-487c-b500-a67fd282a73b |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761388 |
| Active ingredients (FDA) | CROVALIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Piasky, Genentech, Inc., effective November 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →