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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...

Fertility Center of California HCT/P Deviations

[ Price : $8.95]

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

[ 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

[ Price : $8.95]

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

[ Price : $8.95]

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

Emalex Ecopipam Meets Tourette Study Endpoints

[ Price : $8.95]

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

[ Price : $8.95]

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

Contaminated SinuCleanse Nasal Wash Recalled

[ Price : $8.95]

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

Entrada Clinical Hold Lifted on Duchenne Drug

[ Price : $8.95]

FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided aut...

Ex-CDER Head Cavazzoni Rejoins Pfizer

[ Price : $8.95]

Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.