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- FDA advisory committee backs two more peptides, rejects one for compounding listBy the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…raps · 6d ago↗ source
- Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbumpAn unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”BioSpace · 6d ago↗ source
- BeOne commits $300M to US manufacturing expansion, creating 120 new jobsThe addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.