FDA accepts for review a Celgene and Acceleron BLA for luspatercept for treating certain patients with very low to intermediate-risk myelodysplastic s...
FDA approves a TransMedics Group PMA for expanded clinical indications of the Organ Care System Lung to be used for the preservation and ex-vivo asses...
FDA approves a Merck NDA for a new indication for Zerbaxa (ceftolozane and tazobactam) for treating hospital-acquired bacterial pneumonia and ventilat...
FDAs Oncology Center of Excellence unveils a new drug expanded access pilot program to assist oncology health care professionals in requesting access ...
Federal Register notice: FDA withdraws the approval of five ANDAs for products containing pemoline.
Federal Register notice: FDA permits the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (si...
FDA issues a safety alert on the dietary supplement ingredient vinpocetine (aka periwinkle extract) due to its potential to cause a miscarriage or har...
FDA chief of staff Lauren Silvis announces her departure from the agency later this month.