FDA revises form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Applicati...
Three drug and medical device industry trade associations comment positively on an FDA draft guidance on decentralized clinical trials and suggest enh...
FDA approves Taiho Oncologys Lonsurf (trifluridine and tipiracil) with bevacizumab for treating certain metastatic colorectal cancer patients.
FDA converts a BD Respiratory Viral Panel from an emergency use authorization to a cleared 510(k) for detecting Covid-19, influenza A, influenza B, an...
Baxter Healthcare recalls its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety ...
Federal Register notice: FDA determines that progesterone injection, USP, 50 mg/mL, was not withdrawn due to safety or effectiveness issues.
FDA approves a fast-track designation for Invectys IVS-3001 antigen to combat renal cell cancer.
Lupin Pharmaceuticals recalls two lots of Tydemy oral contraceptive tablets due to out-of-specification test results at the 12-month stability time po...
