Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 076251 for Fluoxetine Hydrochloride Capsules (Discontinued)
The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
68 Korean Medicines Face Insurance Price Cuts Starting Sept 1, Pharmacies Warned on Returns
From Sept 1, insurance reimbursement prices for 68 drugs in South Korea will drop, with reductions ranging from under 1% to over 20%; pharmacies must manage inventory differences and physical returns.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA077991 for OTC Cetirizine/Pseudoephedrine Extended‑Release Tablet
The FDA has approved ANDA077991 for an over‑the‑counter oral tablet containing 5 mg cetirizine hydrochloride and 120 mg pseudoephedrine hydrochloride, submitted by PLD Acquisitions.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)
The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.
Regulatory Updates
Sep 4, 2026•1 min read
South Korea to Expand Medication Delivery for All Telemedicine Patients
The Ministry of Health and Welfare will discuss expanding drug delivery to all telemedicine patients and forming a public‑private council to address pharmacist duties in a non‑face‑to‑face setting.
Regulatory Updates
Sep 4, 2026•1 min read
MediBioLab launches GumGoods health supplement using MFDS‑approved PMEC ingredient
MediBioLab released GumGoods, a gum‑health functional food leveraging the MFDS‑approved PMEC propolis extract after eight years of research.
Regulatory Updates
Sep 4, 2026•1 min read
Anguk Pharmaceutical Holds Company-wide Compliance Training on Fair Trade and Legal Risks
Anguk Pharmaceutical organized a company-wide compliance session, inviting lawyer Lee Jong-heon of Jipyung to discuss fair-trade and corporate governance risks across industries.
Regulatory Updates
Sep 4, 2026•1 min read
Opposition Parties Urge Ruling Party to End Boycott of Health Committee and Normalize Parliament
Democratic, Joo Kook Innovation and Progressive Party members of the National Assembly Health and Welfare Committee called on the People Power Party to stop its boycott, appoint committee leadership, and resume legislative work.
Regulatory Updates
Sep 4, 2026•1 min read
Hazardous Ingredients Surge in Overseas Direct‑Purchase Health Foods, 2023‑2025
Detection of medicinal and narcotic substances in imported health foods rose from 281 cases in 2023 to 871 in 2025, a 3.1‑fold increase, raising consumer safety concerns.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves Celcuity's Revtorpyk for HR+/HER2- Breast Cancer (Non‑PIK3CA)
The FDA authorized Celcuity's small‑molecule inhibitor Revtorpyk (gedatolisib) for hormone‑receptor‑positive, HER2‑negative breast cancer without PIK3CA mutations, to be used with fulvestrant and optionally Ibrance.
Regulatory Updates
Sep 4, 2026•1 min read
Novo Nordisk Secures EU Approval for Oral Wegovy Obesity Treatment
Novo Nordisk received European Commission approval for its oral Wegovy for obese or overweight adults, positioning it ahead of Eli Lilly’s pending oral GLP‑1 drug in Europe.
Regulatory Updates
Sep 4, 2026•1 min read
Health Canada Alert: Stryker LifePak R35 Connector Seating Issue
Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.