This section highlights FDA-related milestones and regulatory updates for drugs developed by Grifols (GRFS).
Over the past two years, Grifols has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XEMBIFY and Recombinant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XEMBIFY FDA Regulatory Events
XEMBIFY is a drug developed by Grifols for the following indication: To include treatment-naïve patients with primary humoral immunodeficiencies (PI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XEMBIFY
- Announced Date:
- July 16, 2026
- Indication:
- To include treatment-naïve patients with primary humoral immunodeficiencies (PI).
Announcement
Grifols announced that the first patients have been dosed in two separate Phase 3 trials aiming to expand the U.S. labels for its signature immunoglobulin therapeutics, GAMUNEX®-C, an intravenous immunoglobulin (IVIg), and XEMBIFY®, its subcutaneous immunoglobulin (SCIg).
AI Summary
Grifols said the first patients have been dosed in two Phase 3 trials designed to expand the U.S. labels for its immunoglobulin products, GAMUNEX-C and XEMBIFY. One study, called SIGMA, is testing GAMUNEX-C in people with blood cancers such as chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma who also have low antibody levels. The goal is to show the treatment can help prevent serious bacterial infections. The second study, XPERT, is evaluating XEMBIFY as a maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy, or CIDP, comparing it with GAMUNEX-C.
Grifols said these trials could give patients more treatment options and more flexibility, including intravenous and subcutaneous choices. The company noted that demand for its immunoglobulin products remains strong and that XEMBIFY has seen especially fast growth. Both studies are part of Grifols’ effort to broaden the use of its plasma-derived therapies and support patients with serious immune-related conditions.
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Recombinant Polyclonal FDA Regulatory Events
Recombinant Polyclonal is a drug developed by Grifols for the following indication: For HBV Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Recombinant Polyclonal
- Announced Date:
- November 19, 2024
- Indication:
- For HBV Treatment
Announcement
GigaGen Inc., announced hat the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment of hepatitis B virus (HBV) infection.
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