Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements to the draft.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.
Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements to the draft.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 Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer indication based on data from the company’s LAGOON trial.
Liebel-Flarsheim recalls one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that could pose serious health risks if injected.
