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Regeneron Refiles BLA for Follicular Lymphoma

[ Price : $8.95]

FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.

Generic Mifepristone Maker Wants to Defend Suit

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GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit see...

More FDA Cuts Coming Down the Road

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Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration ...

Fertility Center of California HCT/P Deviations

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FDA warns San Diego, CA-based Fertility Center of California about deviations from regulations governing cells, tissues, and cellu...

Priority Review for Keytruda Head/Neck Cancer sBLA

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locall...

FDA Removes Clozapine REMS Program

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FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of ab...

4 Observations on AstraZeneca FDA-483

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FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.

Emalex Ecopipam Meets Tourette Study Endpoints

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Emalex Biosciences says it will meet with FDA to discuss submitting an NDA for its ecopipam to treat Tourette syndrome following s...

Tandem Diabetes Insulin Algorithm Cleared for Type 2

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FDA clears Tandem Diabetes Cares next-generation automated insulin delivery algorithm, Control-IQ+ technology, for use in people w...

Contaminated SinuCleanse Nasal Wash Recalled

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Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test r...