Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Irbesartan/Hydrochlorothiazide Combination Tablets (ANDA 077446)
The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.
Regulatory Updates
Sep 21, 2026•1 min read
Korean Biochem Pharm Secures Approval for Silodosin‑Rosuvastatin Combination Tablets
Korean Biochem Pharm received regulatory approval for two silodosin‑rosuvastatin sustained‑release tablets, expanding Korean United Pharm’s product line.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Teva Olanzapine/Fluoxetine Combination (ANDA077528)
FDA has approved Teva Pharmaceuticals' ANDA077528 for an oral capsule combining olanzapine and fluoxetine, with several dosage strengths, as of Feb 26 2021.
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 2, 2026•1 min read
FDA Approves Pfizer/Astellas Padcev and Merck Keytruda Combo for All MIBC Patients
The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.
2
Regulatory Updates
Aug 24, 2026•1 min read
MFDS proposes label changes for 134 dapagliflozin/metformin combo products
South Korea's MFDS has drafted an amendment to approval conditions for 134 dapagliflozin‑metformin combination drugs, seeking public comments to unify efficacy, dosage and safety guidance.