Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecting voting and nonvot...
Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Considerations...
FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients with relapsed or refra...
CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge companies to conside...
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.
