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- EMA seeks input on draft revisions to biosimilar efficacy guidanceThe European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
- FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding listThe FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…