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Allovate Illegally Marketing Allerdent, FDA Says

[ Price : $8.95]

FDA warns New York, NY-based Allovate Therapeutics that it is illegally marketing its Allerdent toothpaste that is an unapproved n...

LifeVac Marketing Illegal Airway Device: FDA

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FDA warns Nesconset, NY-based LifeVac that it is illegally marketing and distributing an airway clearance device.

FDA Accepts NDA for Once-Daily ADHD Drug

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FDA accepts for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-defic...

Astellas Pancreatic Cancer Study Misses Endpoint

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An Astellas Phase 2 study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer fails...

Leukemia Treatment Data Sets Guidance

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FDA publishes a guidance with recommendations for submitting clinical trial data sets for response assessments for treatments of a...

Pfizers Tukysa Meets Trial Endpoint

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Pfizer says its Tukysa met the progression-free survival endpoint in the HER2CLIMB-05 breast cancer trial combining Tukysa with st...

FDA Accepts Rockets Gene Therapy BLA Resubmission

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FDA accepts for review a Rocket Pharmaceuticals BLA resubmission for Kresladi (marnetegragene autotemcel), a gene therapy for seve...

Uzedy Expanded to Include Bipolar I Maintenance

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FDA approves an expanded indication for Teva and Medincells Uzedy (risperidone) to permit its use as monotherapy or adjunctive the...

Tvardis Lung Disease Drug Falls Short in Trial

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Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary...

Regeneron Gene Therapy Improved Rare Hearing Loss

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Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all childr...