FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.
GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit seeking to ban the drug...
Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration issues a new memo ca...
FDA warns San Diego, CA-based Fertility Center of California about deviations from regulations governing cells, tissues, and cellular and tissue-based...
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locally advanced head and ...
FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of absolute neutrophil co...
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...
