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Priority Review for Roche Enspryng sBLA

[ Price : $8.95]

FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease...

BMC Medical Recalls Sleep Apnea Machines

[ Price : $8.95]

BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive s...

FDA Partial Clinical Hold on Biohaven Epilepsy Drug

[ Price : $8.95]

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

[ Price : $8.95]

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 ...