Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements to the draft.
FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.
Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indication based on data...
Liebel-Flarsheim recalls one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that ...
The International Council for Harmonization says its electronic common technical document working group has issued updated support materials for versi...
Arrowhead Pharmaceuticals agrees to acquire an FDA Rare Pediatric Disease Priority Review Voucher from an undisclosed third party.
FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...
FDA issues an early alert warning healthcare providers not to use certain Becton Dickinson intraosseous vascular access needle sets after the company ...
