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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
- 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
- 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
- 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
- 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
- FDA] FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to and is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.
- 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
- 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
- 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
- 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
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