Krieger Scientific founder Joseph Morwald says a surge in FDA drug Warning Letters is driven by an industry systemic problem that is being ignored rat...
AdvaMed voices strong public support for the MDUFA 6 commitment reached with FDA.
FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in comb...
The International Medical Device Regulators Forum releases a final document outlining global principles for Predetermined Change Control Plans for upd...
FDA accepts for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing respiratory syncytial ...
FDA calls on small drug dispensers with no more than 25 employees to complete an assessment so the agency can evaluate the dispensers ability to condu...
Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of estrogen patches us...
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs.
