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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locall...[ Price : $8.95]
FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of ab...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.[ 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...[ Price : $8.95]
FDA clears Tandem Diabetes Cares next-generation automated insulin delivery algorithm, Control-IQ+ technology, for use in people w...[ Price : $8.95]
Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test r...[ Price : $8.95]
FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for...[ Price : $8.95]
FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided aut...