Global Drug Approvals April 2026
Global Drug Approvals
April 2026
In April 2026, 12 drugs were approved globally across 6 regions, including the first oral small molecule GLP-1R agonist for obesity, an AAV gene therapy for sensorineural hearing loss, and a CAR-T for relapsed/refractory large B-cell lymphoma. 101 drugs received ERP designations worldwide.
12 approvals across 6 regions — South Korea leads with 5
In April 2026, 12 drugs were approved globally, with 3 in China, 1 in the European Union, 2 in the U.S., 1 in Canada, and 5 in South Korea. Source: April 2026 monthly report, Table 1.
| Drug | Target | Modality | Indication | Developer | Region · Date |
|---|---|---|---|---|---|
| [F-18]Florastamin | PSMA | Small molecule drug | Recurrent / Metastatic Prostate Carcinoma | FutureChem Co., Ltd. | Korea · Apr 30 |
| Anbalcabtagene autoleucel | TIGIT · CD19 · PD-1 | Autologous CAR-T | Primary mediastinal LBCL (recurrent/refractory); DLBCL (recurrent/refractory) | Curocell, Inc. | Korea · Apr 29 |
| Bewintinib | JAK2 | Small molecule drug | Post-PV myelofibrosis; Post-ET myelofibrosis; Primary Myelofibrosis | Hangzhou Bangshun Pharmaceutical | China · Apr 29 |
| Sodium Picosulfate/Potassium Sulfate/Magnesium Sulfate/Simethicone | — | Small molecule drug | Intestinal preparation | Vivozon Pharmaceutical Inc. | Korea · Apr 29 |
| Andamertinib | EGFR | Small molecule drug | EGFR ex20ins mutation NSCLC | Avistone (Ningbo) Biotechnology | China · Apr 29 |
| Semaglutide (Dr. Reddy’s) | GLP-1R | Recombinant polypeptide; Biosimilar | Diabetes Mellitus, Type 2 | Dr. Reddy’s Laboratories Ltd. | Canada · Apr 28 |
| Amlodipine Besylate / Valsartan / Indapamide | NCC · AT1R · L-type calcium channel | Small molecule drug | Essential Hypertension | AHN-GOOK PHARMACEUTICAL | Korea · Apr 28 |
| Acetaminophen / Guaifenesin / Dextromethorphan / DL-Methylephedrine / Bromhexine | adrenergic · COXs · σ1 · NMDA | Small molecule drug | Common Cold | Chong Kun Dang Pharmaceutical | Korea · Apr 23 |
| Lunsotogene parvec-cwha | OTOF | AAV based gene therapy | Hearing Loss, Sensorineural | Regeneron Pharmaceuticals, Inc. | US · Apr 23 |
| Influenza and COVID-19 mRNA Vaccine (Moderna) | SARS-CoV-2 S protein · Influenza HA | Prophylactic vaccine; mRNA vaccine | Influenza; COVID-19 | Moderna Biotech Spain SLU | EU · Apr 20 |
| DTP Combination Vaccine, Adsorbed (CanSino) | — | Combination vaccine; Prophylactic vaccine | Diphtheria; Tetanus; Whooping Cough | CanSino Biologics, Inc. | China · Apr 7 |
| Orforglipron | GLP-1R | Small molecule drug | Obesity; Overweight | Eli Lilly & Co. | US · Apr 1 |
Four notable approvals from April 2026
Selected for first-in-class mechanism, novel modality, or rare disease significance — all data from the April 2026 monthly report.
Orforglipron — first oral small molecule GLP-1R agonist for obesity
Orforglipron is a small molecule drug targeting GLP-1R developed by Eli Lilly & Co. On April 1, 2026, it was approved in the United States for the treatment of Obesity and Overweight — a landmark approval marking the first oral small molecule GLP-1 receptor agonist in a class dominated by injectable peptide biologics.
GLP-1R · Small molecule · Oral · ObesityLunsotogene parvec-cwha — OTOF gene therapy for hearing loss
Lunsotogene parvec-cwha is an AAV-based gene therapy targeting OTOF, developed by Regeneron Pharmaceuticals, Inc. It received FDA Accelerated Approval on April 23, 2026 for sensorineural hearing loss — targeting OTOF (otoferlin) mutations, a genetic cause of severe congenital hearing loss with no prior approved therapy.
OTOF · AAV gene therapy · Sensorineural hearing lossAnbalcabtagene autoleucel — triple-checkpoint CAR-T for lymphoma
Anbalcabtagene autoleucel is an autologous CAR-T therapy targeting TIGIT, CD19, and PD-1, developed by Curocell, Inc. It received approval in South Korea on April 29, 2026 for relapsed/refractory primary mediastinal large B-cell lymphoma and diffuse large B-cell lymphoma. Its simultaneous targeting of three immune checkpoints in a single CAR-T construct is a mechanistically novel approach.
TIGIT · CD19 · PD-1 · CAR-T · LBCLAndamertinib — EGFR ex20ins inhibitor for NSCLC
Andamertinib is a small molecule drug targeting EGFR, developed by Avistone (Ningbo) Biotechnology Co., Ltd. It received NMPA approval in China on April 29, 2026 for EGFR exon 20 insertion (ex20ins) mutation non-small cell lung cancer — a specific EGFR mutation subtype historically resistant to first- and second-generation EGFR inhibitors. It also received Conditional Marketing Approval from the same agency on April 30.
EGFR ex20ins · Small molecule · NSCLC · China101 ERP designations in April 2026
Orphan Drug (37) and Fast Track (22) lead, followed by Priority Review (16) and Breakthrough Therapy (11). Source: April 2026 monthly report, Para 52.
4 signals from the April 2026 approval data
Strategic takeaways derived from the 12 approvals and 101 ERP designations in the April 2026 monthly report.
Orforglipron: oral small molecule breaks injectable GLP-1 dominance
Orforglipron’s FDA approval on April 1, 2026 for obesity marks a structural shift in the GLP-1R drug class. Until this approval, all approved GLP-1R agonists for obesity were injectable peptide biologics (semaglutide, liraglutide, tirzepatide). An oral small molecule GLP-1R agonist from Eli Lilly removes the injection barrier for the largest patient population in metabolic medicine, with a competitive landscape of 770 drugs targeting GLP-1R now including an approved oral agent.
Anbalcabtagene autoleucel: triple-checkpoint CAR-T sets new construct complexity benchmark
Anbalcabtagene autoleucel’s approval in South Korea for DLBCL and primary mediastinal LBCL introduces a CAR-T construct simultaneously targeting TIGIT, CD19, and PD-1 — three immune checkpoints in a single autologous cell therapy. This construct design reflects the evolution of CAR-T engineering toward multi-target approaches designed to overcome tumour microenvironment immunosuppression in addition to direct tumour cell targeting.
Lunsotogene parvec: AAV gene therapy expands to inner ear OTOF mutations
Lunsotogene parvec-cwha’s FDA Accelerated Approval for sensorineural hearing loss marks the entry of AAV gene therapy into cochlear gene correction. OTOF mutations cause autosomal recessive deafness (DFNB9) — a severe congenital hearing loss with no prior approved therapeutic option beyond hearing aids and cochlear implants. Regeneron’s programme signals the expanding addressability of sensory organ genetic disorders with AAV platforms.
South Korea leads April 2026 with 5 approvals spanning CAR-T, diagnostics, and combination drugs
South Korea’s MFDS approved 5 drugs in April 2026 — the most of any region — spanning Anbalcabtagene autoleucel (triple-checkpoint CAR-T, lymphoma), [F-18]Florastamin (PSMA diagnostic radiopharmaceutical, prostate cancer), two small molecule combination products (hypertension and common cold), and an intestinal preparation. This breadth reflects MFDS’s active approval pipeline across oncology, diagnostics, and established therapeutic categories.
Global drug approvals April 2026 — key questions
In April 2026, 12 drugs were approved globally, with 3 in China, 1 in the European Union, 2 in the U.S., 1 in Canada, and 5 in South Korea.
Orforglipron, a small molecule drug targeting GLP-1R developed by Eli Lilly & Co., was approved by the FDA on April 1, 2026 for the treatment of Obesity and Overweight — the first oral small molecule GLP-1R agonist to receive FDA approval for obesity.
In April 2026, there were 101 drugs under Expedited Review pathways worldwide, including 37 Orphan Drug, 2 Rare Pediatric Disease, 11 Breakthrough Therapy, 22 Fast Track, 16 Priority Review, 5 Conditional Marketing Approval, 3 Regenerative Medicine Advanced Therapy, 1 Accelerated Approval, 1 Advanced Therapy Medicinal Products, 1 Commissioner’s National Priority Voucher, 1 Innovative Licensing and Access Pathway, 1 PRIME, and 1 Qualified Infectious Disease Product.
11 Breakthrough Therapy designations were granted in April 2026.
South Korea had the most approvals with 5 drugs approved in April 2026, followed by China with 3.
Lunsotogene parvec-cwha, an AAV-based gene therapy targeting OTOF, developed by Regeneron Pharmaceuticals, Inc., received FDA Accelerated Approval on April 23, 2026 for sensorineural hearing loss.
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report. Represents a snapshot of available records as of April 2026.