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In October 2023, Sharp Services (part of UDG Healthcare) announced the acquisition of Berkshire Sterile Manufacturing (a US-based fill-finish CDMO) for clinical and commercial sterile injectable products

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The ensuing lapse in FDA appropriations meant the agency could not accept any new drug submissions during this fallow period, while the rejection rate for ongoing submissions had already risen from historical rates in the third quarter of 2025

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If you're on FDA-approved tirzepatide (Mounjaro or Zepbound) and taking a regular doctor-approved B12 supplement by mouth, you're in the clear, Duah says