NDA and BLA Calendar Year Approvals
NDA and BLA Calendar Year Approvals
Efficacy Supplement Approvals
Efficacy Supplement Approvals
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor
On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult…
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to…
ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in…
Drug Alerts and Statements
FDA Drug Alerts and Statements
FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder
FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder
Individual Case Safety Reports
This web page is dedicated to the health and regulatory data standard: Individual Case Safety Report
Compounding Quality Center of Excellence | Instructor-Led Trainings
The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The…
Drug Compliance Programs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the…