FDA Review posts the Federal Register notices for the week ending 12/1/2017.
FDA approves Foundation Medicines F1CDx next generation sequencing cancer biomarker test.
FDA approves Mylans Ogivri (trastuzumab-dkst), the first biosimilar to Genentechs Herceptin, indicated for treating patients with breast or metastatic...
Health Research Laboratories and its owner, Kramer Duhon, agree to settle charges brought by the Federal Trade Commission and the state of Maine over ...
Federal Register notice: FDA announces a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. to review an NDA for ciprofloxacin dispersion for i...
Federal Register notice: FDA determines that Scherings Meticorten (prednisone) tablets were not withdrawn from sale for reasons of safety or effective...
FDA accepts for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for use as a local topical...
Federal Register notice: FDA announces the withdrawal of 68 ANDAs from multiple applicants.