FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.
A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.
FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastatic epidermal growth f...
Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety r...
FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affects the elderly with i...
FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicu...
FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.
FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.
