Approvals at a glance

March 2026 saw 22 drugs cleared by regulators across 6 regions. China’s NMPA led by volume, while the FDA delivered the month’s most modality-diverse slate — including two rare-disease gene therapies under Accelerated Approval and the first oral cyclic peptide targeting an immune receptor pathway that had previously been served only by injectables.

United States: 5 approvals including two rare-disease gene therapies

The FDA’s March slate featured exceptional therapeutic diversity. The headline approval was icotrokinra (Janssen Biotech) — a first-in-class oral cyclic peptide targeting IL-23R for plaque psoriasis. It is the first oral agent of its class in this pathway, distinguishing itself from existing injectable biologics that target IL-23 at the ligand level rather than the receptor. Read the full icotrokinra drug profile →

Two rare-disease gene therapy approvals stood out for their modality. Marnetegragene autotemcel (Rocket Pharmaceuticals) is an ex vivo gene therapy for Leukocyte Adhesion Deficiency Type 1 (LAD-1), cleared under Accelerated Approval. Tividenofusp alfa (Denali Therapeutics) is an IDS-targeted Fc fusion protein designed to cross the blood-brain barrier for Mucopolysaccharidosis II (Hunter syndrome), also approved via Accelerated Approval.

Relacorilant (Corcept Therapeutics) addressed platinum-resistant ovarian, fallopian tube, and primary peritoneal carcinomas through glucocorticoid receptor antagonism. Linerixibat (GSK) inhibits ISBT for cholestatic pruritus in primary biliary cholangitis.

China: 8 approvals spanning oncology diagnostics to biosimilars

China’s NMPA led the month in volume with 8 approvals across five modality classes. 99mTc-3PRGD2 (Foshan Rui Diao) is a radionuclide diagnostic for lung cancer targeting the αvβ3 integrin — reflecting China’s growing investment in precision oncology imaging. Recombinant Human Hyaluronidase (Shanghai Bao Pharma) was approved as a drug delivery adjuvant enabling faster subcutaneous absorption of co-administered therapeutics.

On the biologics front, China approved an Insulin Degludec biosimilar (Zhuhai Federal Biomedical) for Type 2 diabetes and a Recombinant EPO stimulating protein (Guangdong Sansheng) for anaemia in chronic kidney disease — both targeting large chronic-disease patient populations. The remaining approvals covered a botulinum toxin aesthetic drug, a tetanus vaccine, and a cardiac agent.

South Korea, Japan, EU & India

South Korea: metabolic combinations lead

South Korea’s MFDS approved 4 drugs in March, three of which were fixed-dose combinations. The most pharmacologically notable was Metformin/Lobeglitazone/Empagliflozin (Chong Kun Dang) — a triple-combination for Type 2 diabetes simultaneously targeting SGLT2, PRKAB1, and PPARγ. Full APAC breakdown →

Japan: PI3Kα inhibitor, MRI contrast, and HIV combo

Japan’s PMDA approved Risovalisib (Haihe Biopharma), a PI3Kα inhibitor for ovarian clear cell carcinoma — a histological subtype historically resistant to platinum-based chemotherapy. Gadoquatrane (Bayer Yakuhin) is a new gadolinium-based MRI contrast agent for CNS imaging, and Doravirine/Islatravir (MSD KK) is a two-drug HIV combination pairing an NNRTI with a nucleoside translocation inhibitor. Full Japan breakdown →

European Union & India

The EMA approved Estetrol (Gedeon Richter) for oestrogen deficiency in postmenopausal women — a naturally occurring oestrogen with a selective receptor modulator profile distinct from conventional HRT. India’s CDSCO cleared a semaglutide biosimilar (NATCO Pharma), entering the increasingly competitive GLP-1R agonist biosimilar field as original semaglutide patents approach expiry in key markets.

104 expedited review designations in March 2026

In parallel with final approvals, 104 drugs received expedited review pathway (ERP) designations globally. Orphan Drug led at 55, followed by Priority Review (14), Fast Track (11), and Breakthrough Therapy (10). Among the BTD highlights: GFH-375 (KRAS G12D inhibitor, pancreatic cancer), YL-201 (ADC, small cell lung cancer), Venglustat (UGCG inhibitor, Gaucher Disease Type 3), and HSK-31679 (THR-β agonist, MASH). Full ERP analysis →

March 2026 in context

March’s 22 approvals reflect several durable trends across pharmaceutical development: the continued rise of gene and cell therapies for rare diseases, ADC and bispecific modalities in oncology, biosimilar competition entering the GLP-1 and insulin spaces, and — most notably — the first oral cyclic peptide clearing an immune target historically served only by injectables.

• Gene therapy momentum: Two US rare-disease gene therapies approved in a single month signals sustained FDA appetite for curative modalities in small patient populations with high unmet need.
• China’s biosimilar build-out: Both insulin and EPO biosimilars in March reflect China’s large-scale effort to replace imported biologics with domestic production across chronic-disease indications.
• Oral immune agents: Icotrokinra opens a new competitive axis in psoriasis and may pressure injectable biologic share over the next 2–3 years, particularly in mild-to-moderate patient segments with strong oral preference.
• ADC & KRAS pipeline signals: Breakthrough Therapy designations for KRAS G12D and CD276-targeting ADC agents signal where next-cycle oncology approvals will cluster through 2027–2028.
• Rare disease acceleration: Venglustat’s BTD for Gaucher Disease Type 3 — a neurological subtype poorly addressed by existing enzyme replacement therapy — underlines the FDA’s continued openness to substrate reduction approaches for hard-to-treat lysosomal storage disorders.