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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 Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
For Immediate Release July 22, 2026 The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful
blog.naver.com · 2026.07.24
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FDA] FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Dise
For Immediate Release August 19, 2026 The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr)
blog.naver.com · 2026.08.21
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FDA] FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Adv
For Immediate Release August 06, 2026 The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a g
blog.naver.com · 2026.08.07
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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 Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Sc
For Immediate Release July 15, 2026 To advance the Trump administration’s actions to safeguard American agriculture, the U.S. Food and Drug Administration today
blog.naver.com · 2026.07.16
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FDA] FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
For Immediate Release July 22, 2026 The U.S. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food
blog.naver.com · 2026.07.23
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FDA] FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with R
For Immediate Release June 15, 2026 On June 12, 2026, the U.S. This approval marks the first FDA-approved treatment for this indication and represents an important
blog.naver.com · 2026.06.16
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FDA] FDA Approves First Single-Dose Generic Treatment for Influenza
For Immediate Release June 17, 2026 The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first si
blog.naver.com · 2026.06.18
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