CBER director Peter Marks says hed like to see aligned global regulations to boost commercialization for gene and cell therapies.
FDA approves an Abbott PMA supplement for Epic Max, a stented tissue valve to treat people with aortic regurgitation or stenosis.
FDA converts Mercks Keytruda immunotherapy from accelerated to full approval for treating certain solid tumors
FDA commissioner Robert Califf tells House appropriators that reported plans on budget cuts of up to 22% being floated by Republican lawmakers would h...
FDA lifts its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in certain patients with ...
Federal Register notice: FDA announces a 5/9 Advisory Committee meeting to discuss a non-RX birth control pill.
Federal Register notice: FDA announces a 5/11 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss an ARS Pharmaceuticals NDA for epinephrine...
Federal Register notice: FDA announces a 4/14 joint advisory committee meeting to discuss an Otsuka Pharmaceutical and Lundbeck supplemental NDA for R...
