FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years and older with Grade ...
CDER compliance officer Yasamin Ameri says FDA will issue about the same number of drug CGMP Warning Letters in 2024 as in 2023.
Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensure that unapproved neurostimulation devices meet t...
The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading efficacy claims for...
BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresectable, recurrent, lo...
A supplemental NDA for Novo Nordisks weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication is withdrawn to add additional d...
FDA tells the DC District Court that a recent Novartis lawsuit that seeks a preliminary injunction to reverse the agencys approval of MSN Laboratories...
FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drugs.
