Federal Register notice: FDA announces an 11/6 Advisory Committee meeting to review a Biogen BLA for aducanumab solution for treating Alzheimers disea...
FDA posts a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within 1 the Regulatory Timeframe.
Federal Register notice: FDA corrects a notice that appeared in the 7/21 Federal Register announcing the withdrawal of approval for two ANDAs from Kad...
Federal Register notice: FDA issues a final rule to allow importation of certain prescription drugs from Canada.
FDA approves a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospital-acquired bacteri...
FDA posts an International Council for Harmonization draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharm...
Bristol Myers Squibb says an Opdivo (nivolumab) Phase 3 trial in patients post-surgery with high-risk, muscle-invasive urothelial carcinoma met its pr...