Regulatory Updates
Sep 1, 2026•1 min read
Oral Obesity Drugs Gain Ground as Novo Nordisk and Eli Lilly Secure Approvals in Europe and US
Novo Nordisk’s Wegovy oral formulation received UK approval, while Eli Lilly’s oral orforglipron (Foundayo) was approved in the US, intensifying competition in the expanding obesity drug market.
Regulatory Updates
Aug 31, 2026•1 min read
Daewoong Pharmaceutical Starts Phase 3 Trial of Pecusclu for Maintenance Therapy in Erosive Esophagitis
Daewoong Pharma has received MFDS approval to begin a domestic Phase 3 study of its new drug Pecusclu (20 mg) aimed at securing a maintenance indication after treatment of erosive esophagitis.
Regulatory Updates
Aug 31, 2026•1 min read
Keytruda gains two Korean approvals, adds bladder, ovarian uses
MSD Korea received MFDS approval for two additional Keytruda combination therapy indications, bringing its Korean portfolio to 5 bladder and 2 ovarian cancer indications, covering 18 cancers and 37 indications overall.
Regulatory Updates
Aug 31, 2026•1 min read
Curocell’s Limkato CAR‑T Therapy Passes First Health‑Insurance Review in Korea
Korea’s first CAR‑T drug Limkato has cleared its initial health‑insurance coverage review, paving the way for prescriptions and sales from the second half of 2024.
Regulatory Updates
Aug 31, 2026•1 min read
G-Cell Immune Cell Therapy Listed in WHO ATC L01XL Category
G-Cell announced that its immune cell therapy ImmuneCell LC has been officially classified by WHO under ATC code L01XL17 for antineoplastic cell and gene therapy.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Court Overturns Rejection of Jointstem Stem Cell Therapy for Osteoarthritis
Seoul Administrative Court ruled in favor of R&L Regenerative Medicine, canceling the MFDS’s 2025 rejection of Jointstem, a stem‑cell treatment for osteoarthritis.
Regulatory Updates
Aug 30, 2026•1 min read
Huons En’s Hagocho Extract Powder Approved as Functional Ingredient for Prostate Health
Huons En, a Huons Group affiliate, secured individual functional ingredient approval (No. 2026-21) from South Korea's MFDS for its Hagocho extract powder, supporting prostate health.
Regulatory Updates
Aug 30, 2026•1 min read
Qurocell's CAR‑T therapy Rimcato clears HIRA severe disease review for insurance coverage
Qurocell announced its CAR‑T drug Rimcato has passed the HIRA Severe Disease Review Committee, clearing the first hurdle for national health‑insurance reimbursement.
Regulatory Updates
Aug 30, 2026•1 min read
South Korea’s First Domestic CAR‑T Therapy Rimkatoju Clears Initial Health‑Insurance Hurdle
Rimkatoju, Korea’s first home‑grown CAR‑T drug, passed the first review for national health‑insurance reimbursement, while HER2‑positive breast cancer drug Purgeta’s expansion was postponed.
Regulatory Updates
Aug 30, 2026•1 min read
Lotte Biologics Obtains Use Approval for Phase‑1 Plant at Songdo Bio Campus
Lotte Biologics announced on the 22nd that its Phase‑1 facility at Incheon’s Songdo Bio Campus has received use approval, marking completion of major construction within about two years.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078132 for Discontinued Ibuprofen Tablet Products
FDA listed approval for ANDA078132 submitted by Northstar Healthcare covering oral ibuprofen tablets (400 mg, 600 mg, 800 mg) now marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Claudin18.2‑Targeted CAR‑T Therapy Achieves First Global Approval for Solid Tumor
Claudin18.2‑targeted CAR‑T therapy is the first CAR‑T to receive global approval for a solid tumor.