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...
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Innovation Network.
