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FDA Partial Clinical Hold on Biohaven Epilepsy Drug

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FDA issues a partial clinical hold on Biohavens opakalim (BHV-7000) due to nonclinical characterization of certain metabolites doc...

3 Observations on XeCare FDA-483

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FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.

FDA Open to Alternative Approaches For Psychedelic Drug Trials

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Writing in a in a New England Journal of Medicine article, FDA officials encourage novel approaches for developing psychedelic dru...

Bill to Update FDA Drug Preclusion Rules

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Rep. Diana Harshberger introduces legislation to aid the dietary supplement industry by changing FDAs drug preclusion rules.

Reduced Application Fees Not Sufficient Incentive: Column

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Ovid Therapeutics executive chairman Jeremy Levin says FDA needs to speed its regulatory processes if it wants to persuade compani...

Bayer Gets OK for Lung Cancer Drug

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FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally adv...

FDA Still Reviewing Rezolute Phase 3 Info

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Rezolute says FDA is still reviewing the additional data the agency requested from the companys Phase 3 sunRIZE trial of ersodetug...

Nanoscope BLA Accepted for Vision Restoration Gene Therapy

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FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision ...

Accelerated Rare Disease Cures Program Strategic Plan Out

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The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each...

AstraZeneca Reports Positive Data on COPD Biologic

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AstraZeneca reports data from the Phase 3 OBERON and TITANIA trials showing that tozorakimab is the first biologic to demonstrate ...