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- Amgen submits new analysis to FDA to defend continued availability of TavneosAmgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
- FDA panel backs compounding of epitalon, rejects emideltide in narrow voteThe FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…