FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.
Emalex Biosciences says it will meet with FDA to discuss submitting an NDA for its ecopipam to treat Tourette syndrome following successful results fr...
FDA clears Tandem Diabetes Cares next-generation automated insulin delivery algorithm, Control-IQ+ technology, for use in people with Type 2 diabetes....
Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test result of microbial c...
FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided authorization to begin ...
Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.
FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Parkinsons patients.
FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Administrations cost-cuttin...
