CDERs Office of Prescription Drug Promotion says a professional promotional banner for Neulasta gives false and misleading claims about the drugs bene...
FDA denies a Janssen petition seeking to impose restrictions on ANDAs and NDAs citing the companys Invega Sustenna as the reference-listed drug.
FDA lifts a partial clinical hold against Ryvu Therapeutics and its Phase 1b dose escalation clinical trial of RVU120 (also known as SEL120) in patien...
An unidentified petitioner asks FDA not to approve an NDA for United Therapeutics Tyvaso DPI without trial results showing it is safe for patients wit...
Acting FDA commissioner Janet Woodcock defends the agencys Aduhelm approval but says the process could have been handled less controversially.
ACRA McMeekin announces FDA's first FDA Inspectional Affairs Council meeting this week to discuss optimizing agency inspections on an enterprise- or c...
Three top CDER officials say their decision to grant accelerated approval to Biogens Aduhelm was consistent with the requirements for accelerated appr...
The CDER Office of Prescription Drug Promotion plans to study how healthcare professionals respond to prescription drug exhibit booths at medical conf...