International Major Drug Approvals (US FDA)
1. Awiqli (Insulin icodec-abae)
- Approval Date: March 26, 2026
- Indication: First once-weekly basal insulin for glycemic control in adults with Type 2 diabetes.
2. Jideytro (Zidesamtinib)
- Approval Date: February 20, 2026
- Indication: Targeted therapy for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
3. Trutakna (Atacicept-vymj)
- Approval Date: February 23, 2026
- Indication: Treatment to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy at risk of disease progression.
4. Utebzi (Tebipenem pivoxil)
- Approval Date: June 17, 2026
- Indication: Oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, with limited alternative options.
5. Veppanu (Vepdegestrant)
- Approval Date: May 1, 2026
- Indication: Targeted therapy for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
6. Icotyde (Icotrokinra)
- Approval Date: March 17, 2026
- Indication: First-in-class targeted oral peptide therapy for moderate-to-severe plaque psoriasis in patients 12 years and older.
7. Lifyorli (Relacorilant)
- Approval Date: February 27, 2026
- Indication: Selective cortisol modulator for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
8. Simtriyo (Centanafadine)
- Approval Date: March 24, 2026
- Indication: Triple reuptake inhibitor for the treatment of attention-deficit hyperactivity disorder (ADHD).
9. Lipfendra (Enlicitide decanoate)
- Approval Date: May 15, 2026
- Indication: Long-acting subcutaneous therapy to reduce low-density lipoprotein (LDL) cholesterol in adults with hypercholesterolemia.
10. Lumvoa (Veligrotug-vvze)
- Approval Date: June 26, 2026
- Indication: Monoclonal antibody for active thyroid eye disease (TED).
Major Drug Approvals in India (CDSCO / DCGI)
1. Trastuzumab Deruxtecan (Enhertu)
- Approval Date: July 27, 2026
- Indication: Targeted antibody-drug conjugate (ADC) approved for HER2-positive early and metastatic breast cancer.
2. Amivantamab Liquid Concentrate
- Approval Date: July 27, 2026
- Indication: Bispecific antibody for EGFR exon 20 insertion-mutated non-small cell lung cancer (NSCLC).
3. Semaglutide Prefilled Pen & Cartridge
- Approval Date: July 22, 2026
- Indication: Prefilled injectable formulations approved for Type 2 diabetes management and glycemic control.
4. Vonoprazan + Amoxicillin + Clarithromycin Combipack
- Approval Date: July 23, 2026
- Indication: Potassium-competitive acid blocker (P-CAB) combination therapy for Helicobacter pylori eradication.
5. Dapagliflozin + Linagliptin Fixed-Dose Combination (FDC)
- Approval Date: July 22, 2026
- Indication: Dual-action SGLT2 inhibitor + DPP-4 inhibitor combination for Type 2 diabetes inadequately controlled on metformin.
6. Brexpiprazole Tablets (0.25 mg to 4 mg)
- Approval Date: March 31, 2026
- Indication: Second-generation atypical antipsychotic approved for the treatment of schizophrenia and major depressive disorder.
7. Revefenacin Inhalation Solution (175 mcg/3 mL)
- Approval Date: July 22, 2026
- Indication: Long-acting muscarinic antagonist (LAMA) maintenance treatment for chronic obstructive pulmonary disease (COPD).
8. Durvalumab Concentrate for Infusion
- Approval Date: March 31, 2026
- Indication: PD-L1 immune checkpoint inhibitor approved for biliary tract cancer and non-small cell lung cancer indications.
9. Eslicarbazepine Acetate
- Approval Date: March 31, 2026
- Indication: Voltage-gated sodium channel blocker for adjunctive treatment of partial-onset seizures in epilepsy.
10. Monovalent Inactivated Polio Bulks (Types 1, 2, and 3)
- Approval Date: July 24, 2026
- Indication: Indigenous manufacturing clearance (Biological E) for inactivated polio vaccine (IPV) production to support global immunization programs.