Federal Register notice: FDA announces a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss decongestant phenylephrine.
ADC Therapeutics pauses new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab i...
Three stakeholders praise an FDA guidance on adding clinical outcome assessments to patient-focused drug development regulatory decision-making and su...
Megadyne recalls its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving burn reports affecting pediatric and adult patients.
Two stakeholders respond positively to a recent FDA workshop on innovative drug manufacturing techniques.
FDA says it no longer sees the potential for excess mortality in paclitaxel-coated devices used to treat peripheral arterial disease.
FDA publishes a draft guidance recommending how to optimize and standardize dietary management in clinical trials of drugs to treat inborn errors of m...
Federal Register notice: FDA sends to OMB an information collection extension entitled Emergency Use Authorization of Medical Products and Related Aut...
