[ Price : $8.95]
Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA ...[ Price : $8.95]
Federal Register notice: FDA reopens the comment period for its proposed administrative order entitled Amending Over-the-Counter M...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers on several issues relating to p...[ Price : $8.95]
FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years a...[ Price : $8.95]
CDER compliance officer Yasamin Ameri says FDA will issue about the same number of drug CGMP Warning Letters in 2024 as in 2023.[ Price : $8.95]
Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensure that unapproved neurostimul...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading...[ Price : $8.95]
BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresec...