Regulatory Updates
Aug 30, 2026•1 min read
Korean AbbVie’s JAK inhibitor Rinbark gains EMA endorsement for alopecia areata and vitiligo
AbbVie’s JAK inhibitor Rinbark (upadacitinib) received positive CHMP recommendations to add severe alopecia areata and non‑segmental vitiligo to its label, expanding its autoimmune portfolio.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA084351 for Brompheniramine Maleate 4 mg Tablet (Now Discontinued)
The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA080126 for STANOZIDE Isoniazid Tablets (Everylife)
The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.
Regulatory Updates
Aug 29, 2026•1 min read
FDA Approves ANDA083089 for Propoxyphene Hydrochloride Capsules (Roxane)
FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.
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Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves Padagis Israel’s Desoximetasone 0.25% Topical Ointment (ANDA077770)
The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Approves SHINSA CDx for Identifying Eligible Patients
Japan’s PMDA has approved the SHINSA companion diagnostic (CDx) to help identify patients eligible for specific therapies, updated June 16, 2026.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes English Translation of RiHEART Review Report
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of its review report for the pharmaceutical product RiHEART, available on its website.