About BeSafeRx
“FDA’s BeSafeRx: Your Source for Online Pharmacy Information” is a national campaign to educate consumers and health care professionals about…
Tyche Industries Ltd – 693081 – 02/06/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp – 698782 – 01/29/2025
CGMP/Finished Pharmaceuticals/Adulterated
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