Regulatory Updates
Sep 17, 2026•1 min read
Professor Hong Highlights Gaps in Pricing Reform for Chronic Disease Innovative Drugs
Despite focus on rare disease and oncology, Korea's drug price reform still limits innovative treatments for common chronic conditions, says Seoul National University economist.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
PRAMIPEXOLE DIHYDROCHLORIDE Extended‑Release Tablets Approved (ANDA202353)
FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Diphynoxylate Hydrochloride/Atropine Sulfate Tablet (ANDA 087934)
FDA records show ASCOT's oral tablet containing diphenoxylate hydrochloride 2.5 mg and atropine sulfate 0.025 mg is listed as discontinued under ANDA 087934.
Regulatory Updates
Sep 15, 2026•1 min read
Korea’s First Domestic CAR‑T Therapy Rimkato Secures Reimbursement Approval, Targeting 2026 Commercial Launch
Qurocell’s CAR‑T product Rimkato (anvalkaptagen autologous cell) has cleared the Cancer Disease Review Committee and the Drug Reimbursement Evaluation Committee, opening the path to health‑insurance coverage and a potential market launch within the year.
Regulatory Updates
Sep 14, 2026•1 min read
Korean Lawmakers Urge Prioritizing Rare Disease Policies
Lawmakers and the Korean Rare & Intractable Disease Association held a press conference urging that rare disease patients not be sidelined in policy priorities.
Regulatory Updates
Sep 14, 2026•1 min read
Korea's first domestically developed CAR‑T therapy Rimkato clears drug reimbursement evaluation
The domestically developed CAR‑T drug Rimkato (Anbalcapatgen Autolyscel) cleared the drug reimbursement evaluation committee, moving closer to inclusion in national health‑insurance coverage.
Regulatory Updates
Sep 14, 2026•1 min read
MHRA Field Safety Notices Published 7‑11 Sep 2026
MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.
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Regulatory Updates
Sep 13, 2026•1 min read
Korean Government Proposes Nationwide Telemedicine Prescription Delivery; Free‑Medical‑Care Movement Calls for Immediate Halt
The government plans to expand telemedicine prescription drug delivery to all patients, prompting the Free‑Medical‑Care Movement to demand an immediate stop, citing profit motives of private platforms.
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Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA081213 for ESTROPIPATE Oral Tablet
The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.
Regulatory Updates
Sep 12, 2026•1 min read
Korea bans telemedicine prescriptions for newly reimbursed Fintepla and Dayvigo insomnia drug
Fintepla (fenfluramine HCl) entered insurance coverage on the 1st and was immediately classified as a telemedicine‑prescription‑prohibited drug. Dayvigo film‑coating tablets for insomnia were also added to the prohibited list.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA 076335 for TRI-PREVIFEM Oral Tablet
The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.