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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FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.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FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...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...

CDER Approved 50 Novel Products Last Year

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CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...

Ionis Spinraza Approved by FDA for SMA

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FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.

FDA OKs Arrays Braftovi for Some Cancers

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FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

Alcon Recalls Systane Ultra PF Eye Drops

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FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.