FDA approves a Novo Nordisk NDA for Ozempic (semaglutide) injection 0.5 mg and 1 mg, a once-weekly glucagon-like peptide receptor agonist for adults w...
Federal Register notice: FDA makes available a guidance entitled Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infe...
CDRH UDI regulatory policy analyst Christina Savasaar says two key changes were made between draft and final guidances on UDI direct marking.
Advocacy group Public Citizen petitions FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified by the agency as pre...
Two FDAers say the agency has issued a Predictive Toxicology Roadmap and will hold a public workshop to help foster opportunities for sharing ideas on...
FDA grants full approval for Genentechs Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prior therapy.
Federal Register notice: FDA extends the comment period on a 9/8 notice seeking input on existing regulations and related paperwork requirements that ...
FDA accepts for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for managing moderate-to...