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 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.
