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...
FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in comb...
FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.
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 ...
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...
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...
FDA signals that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estima...
