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Human Drugs

Dizal Lung Cancer NDA Accepted for Priority Review

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

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Human Drugs

5 Repeat CGMP Violations at Indoco Remedies

FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.

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Human Drugs

FDA Obesity/Overweight Drug Development Guide

FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.

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Off-Label Communications Q&A Guide

FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or cleared medical produ...

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Human Drugs

Rybrevant/Lazcluze Cancer Study Positive: J&J

Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically signific...

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Federal Register

Jiao Debarment Notice Corrected

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

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Human Drugs

2 ALS Drugs Miss Endpoints

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

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Medical Devices

Lifecycle Recommendations for AI-Enabled Devices

FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...

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Sex Differences in Clinical Evaluations of Products

FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.

Biologics

RSV Vaccines Get Guillain-Barr Warning

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