FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.
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 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...
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...
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.
