[ Price : $8.95]
AdvaMed voices strong public support for the MDUFA 6 commitment reached with FDA.[ Price : $8.95]
FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic vi...[ Price : $8.95]
The International Medical Device Regulators Forum releases a final document outlining global principles for Predetermined Change C...[ Price : $8.95]
FDA accepts for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing re...[ Price : $8.95]
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs...[ Price : $8.95]
FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing...[ Price : $8.95]
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.[ Price : $8.95]
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Inno...