FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the identification of a c...
Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial invol...
An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy nasal spray.
Public Citizen asks a federal court to order the Trump administration to make public the terms of drug pricing deals it signed with Pfizer and Lilly.
An Akin legal update says FDAs recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home bl...
FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the companys Torrance, C...
HHS Office of Inspector General issues new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs directly to patients enro...
FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.
