US & EU Drug Approvals — March 2026
US & EU Drug
Approvals — March 2026
The FDA approved 5 drugs in March 2026 including a gene therapy for a rare primary immunodeficiency, a first-in-class GR inhibitor for platinum-resistant ovarian cancers, and a novel ISBT inhibitor for cholestatic pruritus. The EMA approved 1 drug for oestrogen deficiency.
5 drugs approved by the FDA — March 2026
Spanning gene therapy, oncology, rare metabolic disease, dermatology, and hepatology. All data from the March 2026 monthly report, Table 0.
| Drug | Target | Modality | Indication | Developer | Date |
|---|---|---|---|---|---|
| Marnetegragene autotemcel | CD18 | Gene therapy; Hematopoietic stem cell therapy | Leukocyte Adhesion Deficiency Type 1 | Rocket Pharmaceuticals, Inc. | Mar 26 |
| Relacorilant | GR | Small molecule drug | Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Platinum-Resistant Epithelial Ovarian Carcinoma | Corcept Therapeutics, Inc. | Mar 25 |
| Tividenofusp alfa | IDS | Fc fusion protein | Mucopolysaccharidosis II | Denali Therapeutics, Inc. | Mar 24 |
| Icotrokinra | IL-23R | Synthetic peptide; Cyclic peptide | Plaque psoriasis | Janssen Biotech, Inc. | Mar 17 |
| Linerixibat | ISBT | Small molecule drug | Cholestatic pruritus | GlaxoSmithKline LLC | Mar 17 |
1 EMA approval, 1 India approval — March 2026
Estetrol approved in the EU for oestrogen deficiency; Semaglutide biosimilar approved in India for Type 2 diabetes.
| Drug | Target | Modality | Indication | Developer | Region · Date |
|---|---|---|---|---|---|
| Estetrol | ER | Small molecule drug | Oestrogen deficiency | Chemical Works of Gedeon Richter Plc | EU · Mar 26 |
| Semaglutide biosimilar (Natco Pharma) | GLP-1R | Recombinant polypeptide; Biosimilar | Diabetes Mellitus, Type 2 | NATCO Pharma Ltd. | India · Mar 20 |
4 signals from the US & EU March 2026 approval data
Strategic takeaways derived from the 7 approvals in the March 2026 monthly report.
Marnetegragene autotemcel: CD18 gene therapy approved for ultra-rare LAD-1
Marnetegragene autotemcel, a CD18-targeting gene therapy and hematopoietic stem cell therapy developed by Rocket Pharmaceuticals, Inc., received FDA Accelerated Approval on March 26, 2026 for Leukocyte Adhesion Deficiency Type 1 — an ultra-rare primary immunodeficiency with no previously approved curative therapy. CD18 encodes the beta-2 integrin subunit, deficiency of which prevents neutrophil adhesion and migration, causing life-threatening infections.
Relacorilant: GR inhibition as a new approach to platinum-resistant ovarian cancers
Relacorilant, a glucocorticoid receptor (GR) inhibitor developed by Corcept Therapeutics, Inc., received FDA approval on March 25, 2026 for three platinum-resistant ovarian cancer indications: Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, and Epithelial Ovarian Carcinoma. GR inhibition as a strategy in platinum-resistant gynaecological malignancies represents a mechanistically novel approach to a population with very limited standard-of-care options.
Tividenofusp alfa: IDS Fc fusion protein for MPS II with CNS penetration ambition
Tividenofusp alfa, an iduronate-2-sulfatase (IDS) Fc fusion protein developed by Denali Therapeutics, Inc., received FDA Accelerated Approval on March 24, 2026 for Mucopolysaccharidosis II (Hunter syndrome). Denali’s Fc fusion platform is designed to enable blood-brain barrier penetration via the transferrin receptor, addressing the neurological manifestations of MPS II that conventional enzyme replacement therapy cannot reach.
Semaglutide biosimilar approved in India: GLP-1 access expands in high-burden markets
NATCO Pharma Ltd. received approval in India on March 20, 2026 for a Semaglutide biosimilar (GLP-1R, recombinant polypeptide) for Type 2 diabetes. India carries one of the world’s largest Type 2 diabetes burdens, and a domestic semaglutide biosimilar creates meaningful affordability and access impact relative to originator Ozempic/Wegovy pricing. This approval signals the beginning of GLP-1 biosimilar competition in major emerging markets.
US & EU drug approvals March 2026 — key questions
The FDA approved 5 drugs in March 2026: Marnetegragene autotemcel (CD18 gene therapy, LAD-1), Relacorilant (GR inhibitor, platinum-resistant ovarian cancers), Tividenofusp alfa (IDS Fc fusion protein, Mucopolysaccharidosis II), Icotrokinra (IL-23R synthetic cyclic peptide, plaque psoriasis), and Linerixibat (ISBT inhibitor, cholestatic pruritus).
Marnetegragene autotemcel, a CD18-targeting gene therapy and hematopoietic stem cell therapy developed by Rocket Pharmaceuticals, Inc., received FDA approval on March 26, 2026 for Leukocyte Adhesion Deficiency Type 1 (LAD-1). The approval was an Accelerated Approval.
Estetrol, a small molecule drug targeting ER (estrogen receptor) developed by Chemical Works of Gedeon Richter Plc, received European Union approval on March 26, 2026 for oestrogen deficiency.
Relacorilant, a GR (glucocorticoid receptor) inhibitor small molecule drug developed by Corcept Therapeutics, Inc., was approved by the FDA on March 25, 2026 for Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, and Platinum-Resistant Epithelial Ovarian Carcinoma.
Tividenofusp alfa, an IDS Fc fusion protein developed by Denali Therapeutics, Inc., received FDA Accelerated Approval on March 24, 2026 for Mucopolysaccharidosis II (MPS II, Hunter syndrome).
Linerixibat, an ISBT (ileal sodium/bile acid transporter) inhibitor small molecule drug developed by GlaxoSmithKline LLC, was approved by the FDA on March 17, 2026 for cholestatic pruritus.
Data on this page is sourced from the PatSnap March 2026 monthly pharmaceutical report, Table 0 (drug approvals). Represents a snapshot of available records as of March 2026.