FDA sends an email to Praxis Precision Medicines that placed a clinical hold on PRAX-222, an antisense oligonucleotide for treating patients with SCN2...
FDA warns healthcare providers about the possibility that patients who have Medtronics Heartware Ventricular Assist Device System and appear to presen...
CDERs Office of Compliance (OC) says its priorities for 2022 include supporting FDAs Covid-19 response , reducing harm caused by opioid crisis, and im...
FDA posts a draft guidance entitled Crohns Disease: Developing Drugs for Treatment that discusses clinical trial considerations.
Federal Register notice: FDA issues a priority review voucher to Gilead Sciences under the agencys material threat medical countermeasure program.
FDA lifts a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical d...
FDA announces the tentative Vaccines and Related Biological Products Advisory Committee schedule that has five separate dates the panel will meet to r...
FDA posts a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment.