Lexicon asks that its NDA for sotagliflozin be approved to treat Type 1 diabetes or that a hearing be held to resolve issues of fact about the NDA.
Five stakeholders recommend changes to an FDA proposed rule on nonprescription drug products with an additional condition for nonprescription use.
Roche withdraws a Tecentriq (atezolizumab) accelerated approval indication for treating certain adults with locally advanced or metastatic urothelial ...
Federal Register notice: FDA withdraws the approval of Mylans Sulfamylon (mafenide acetate, USP) powder for 5% topical solution after the company requ...
Researchers document the Medicare savings associated with skinny label biosimilars.
Republican Sen. Richard Burr says the lame-duck session of Congress will not consider reforming FDA oversight of dietary supplements.
Federal Register notice: FDA issues an order debarring Jennings Ryan Staley for five years from importing or offering for import any drug into the U.S...
FDA grants Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or refractory large B ...
