The CBER Office of Compliance and Biologics Quality cautions Scarsdale Integrative Family Medicine that it is marketing unapproved cellular products a...
Federal Register notice: FDA determines that Mercks Stromectol (ivermectin) tablets, 6 mg, were not withdrawn from sale for reasons of safety or effec...
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...