FDA approves eight smokeless tobacco products under the new modified risk tobacco product pathway.
FDA accepts for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film for treating acute mi...
FDA releases its latest batch of Warning Letters that includes Jiangsu NHWA Pharmaceutical Co. and Sofie Co.
Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.
FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthetic knees.
FDA makes available a draft guidance entitled Drug Master Files.
Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathy...