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Priority Review for Keytruda Head/Neck Cancer sBLA

[ Price : $8.95]

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...

OTC Shampoo Suit Preempted by FDA Monograph

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Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state cl...

Janssen Vaccines FDA-483

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FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, ...

Detailed Comments on Protocol Deviations Draft Guide

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Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.

Precigen BLA for Respiratory Papillomatosis Therapy

[ Price : $8.95]

FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy f...