- Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies<p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>raps · 1d ago↗ source
- Study: Most sponsors complete postmarketing trials, publish results<p>Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the…raps · 1d ago↗ source
- FDA advisory committee backs two controversial peptides<p>An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for woun…