FDA Grants Breakthrough Therapy Designation to Tividenofusp Alfa for Treatment of Hunter Syndrome
January 9th 2025Regulatory action could help patients with Hunter syndrome who have cognitive and behavioral complications and often do not have an effective treatment crossing the blood-brain barrier.
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FDA Requires Warning for Guillain-Barré Syndrome in Prescribing Information for RSV Vaccines
January 7th 2025Despite these concerns, experts have emphasized that the benefits of RSV vaccination outweigh potential risks for older adults, who are at heightened risk of severe RSV-related illness.
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The Future of Cancer Drug Development: Advancements, Challenges, and the Transformative Role of AI
January 7th 2025AI is revolutionizing oncology drug development, enhancing therapeutic identification and reducing approval times, but use of this tool must be carefully implemented to mitigate risks and ensure regulatory compliance.
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