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FDA] FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical
For Immediate Release August 18, 2026 The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative a
blog.naver.com · 2026.08.19
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FDA] FDA Proposes Rule to Modernize Drug Manufacturing Registration
For Immediate Release July 10, 2026 The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registrati
blog.naver.com · 2026.07.13
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FDA] FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multipl
For Immediate Release August 07, 2026 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical
blog.naver.com · 2026.08.10
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FDA] FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and
For Immediate Release August 13, 2026 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, mox
blog.naver.com · 2026.08.14
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FDA] FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms
For Immediate Release August 05, 2026 The U.S. Food and Drug Administration today approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1
blog.naver.com · 2026.08.06
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FDA] FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.
blog.naver.com · 2026.07.23
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FDA] FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Chol
For Immediate Release July 17, 2026 The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase sub
blog.naver.com · 2026.07.20
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FDA] FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications
For Immediate Release June 30, 2026 The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for impr
blog.naver.com · 2026.07.01
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FDA] FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufactur
Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 14293
blog.naver.com · 2026.06.30
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FDA] FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone This action aligns with President Trump’s Great American Recovery Initiative, a federal effort to address
blog.naver.com · 2026.06.17
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