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Jiao Debarment Notice Corrected

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Federal Register notice: FDA corrects a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilso...

2 ALS Drugs Miss Endpoints

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Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet pri...

Lifecycle Recommendations for AI-Enabled Devices

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FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...

Sex Differences in Clinical Evaluations of Products

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FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.

RSV Vaccines Get Guillain-Barr Warning

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FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) ...

Optical Imaging Drug Development Guidance

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FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.

Dizal Lung Cancer NDA Accepted for Priority Review

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FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic ...

Guide on Clinical Trials Using Tissue Biopsies

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FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.

Draft Guide on Using AI for Drug Development

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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...

Neumoras Phase 3 Depression Study Misses Endpoints

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Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...