Regulatory Updates
Sep 1, 2026•1 min read
FDA Temporarily Suspends CRL Publication Policy
The FDA has paused its real‑time release of complete response letters after a citizen petition, with HHS reviewing the procedure.
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Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Multiple Submissions for CYCLOCORT Topical Cream (NDA018116)
The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.
Regulatory Updates
Aug 31, 2026•1 min read
Myeongin Pharma Advances Parkinson’s Drug P2B001 Toward Korean Approval
Myeongin Pharma seeks Korean approval for P2B001, the world’s first extended‑release Parkinson’s combination drug, as it shifts toward global R&D.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves PROGLYCEM (Diazoxide) Oral Suspension – NDA 017453
The FDA approved PROGLYCEM, an oral suspension of diazoxide (50 mg/mL) from Teva Pharmaceuticals, under application NDA 017453.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves TECHNESCAN HDP (NDA018321) for Intravenous Use
The FDA has approved TECHNESCAN HDP (NDA018321), a technetium‑99m oxidronate injection manufactured by Curium US LLC.
Regulatory Updates
Aug 30, 2026•1 min read
FDA halts Sobi's gout drug challenger to Amgen's Krystexxa
The FDA has put Sobi's planned gout medication on hold, delaying its challenge to Amgen's Krystexxa.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Manufacturing Submissions for XYLOCAINE Ointment (NDA 008048)
The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.
Regulatory Updates
Aug 25, 2026•2 min read
EMA CHMP July 2026 Meeting Recommends 12 New Medicines and Multiple Extensions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended twelve new medicines for approval and issued several positive, negative and withdrawal decisions on other products.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes List of Approved Drugs (April 2004 – Feb 2026)
Japan’s Pharmaceuticals and Medical Devices Agency has released an updated list of drugs approved from April 2004 through February 2026. The list is available on the PMDA website.