FDA signals that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estima...
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 ...
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs.
FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes ar...