Regulatory Updates
Sep 11, 2026•1 min read
Korean Merck Healthcare’s Pergoberis® Pen Added to Health Insurance Coverage
Pergoberis® Pen, an infertility treatment, will be reimbursed under Korea’s health insurance from Sep 1, covering all three dosage strengths.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Hikma Deferoxamine Mesylate Injectable (ANDA078086)
FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Reports Discontinuation of Multiple THORAZINE Products
The FDA’s database shows several THORAZINE oral, rectal, and injectable products marked as discontinued, with a Federal Register note that discontinuations were not for safety or effectiveness reasons.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves NDA017780 for PHARM SPEC Heparin Sodium Injection
FDA approved NDA017780 for PHARM SPEC's Heparin Sodium injectable products, listing five strengths now marked discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Lupin Generic Levetiracetam Tablets (ANDA 078154)
The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077766 for Simvastatin Generic Tablets
The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077165 for Granisetron Hydrochloride Preservative‑Free Injection (DR REDDYS)
The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080693 for Hydrocortisone 1% Topical Cream
The FDA has approved application ANDA080693 for a prescription 1% hydrocortisone topical cream marketed as HYDROCORTISONE by Fougera Pharm Inc.
Regulatory Updates
Sep 7, 2026•1 min read
Four Experts Appointed as Direct Advisors to Korean National Assembly Speaker, Including Former MFDS Chief
The Korean National Assembly Speaker appointed four advisors—former MFDS head Jeong Seung among them—to guide policy on innovation growth, finance, future growth, and culture.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Labeling Updates for Discontinued Fenofibrate Tablet Products (ANDA 076520)
The FDA has approved a series of labeling submissions for three discontinued oral fenofibrate tablet products (54 mg, 107 mg, 160 mg) under ANDA 076520, with approvals spanning 2005‑2021.
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
Dongguk Pharmaceutical's Rosutanmet Tablets Lose Health Insurance Coverage After Approval Cancellation
Two Dongguk Pharmaceutical Rosutanmet tablet products (500/5 mg and 500/10 mg) will have health‑insurance reimbursement stopped from the 28th after the Daejeon regional authority cancelled their approvals.