FDA accepts for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy.
Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants.
Federal Register notice: CDRH announces its 2019 Experiential Learning Program.
FDA Review posts the Federal Register notices for the week ending 7/27/2018.
FDA issues INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.
FDA clears a Cepheid 510(k) for the Xpert Xpress Flu/RSV test.
Federal Register notice: FDA makes available a draft guidance entitled Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that...
Federal Register notice: FDA makes available a final guidance entitled Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpop...