Regulatorische Updates

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.

The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.

FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.

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.

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.

Lawmakers and the Korean Rare & Intractable Disease Association held a press conference urging that rare disease patients not be sidelined in policy priorities.

The domestically developed CAR‑T drug Rimkato (Anbalcapatgen Autolyscel) cleared the drug reimbursement evaluation committee, moving closer to inclusion in national health‑insurance coverage.

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.

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.

The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.

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.

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.