The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...

Epicrispr Biotechnologies (“Epicrispr”), a clinical-stage company pioneering gene-modulating therapies, and Forge Biologics (“Forge”), a leading manufacturer of gene therapies and member of the ...

Reducing physical segregation and other engineering controls in favor of procedural controls increases Quality burden and often raises long-term operating costs versus robust upfront design. Lifecycle ...

The life science industry faces opportunities in enhancing cGMP compliance by developing robust, risk-based Validation and Verification strategies. Training on creating effective Master Validation ...

This new facility will expand TPI's actinium-225 production twentyfold. BELLEVUE, Wash., March 17, 2026 /PRNewswire/ -- TerraPower Isotopes® (TPI®) announced today that the company is building its ...

The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

FibroBiologics Inc. FBLG on Monday released the first batch of its CYWC628 drug product to support its Phase 1/2 clinical ...

Thanks to the approval by the Italian Medicines Agency (AIFA), the Company increases its efficiency and is able to face the growing demand for its services. MILAN--(BUSINESS WIRE)--Dipharma Francis ...

Two highly similar molecules with essential but often contrasting signaling roles in most life forms exert their distinct effects through subtle differences in their bindings to their signaling ...

Celltrion Inc. announced plans to acquire from Eli Lilly and Co. a Branchburg, N.J.-based biologics cGMP facility for $330 million up front, with plans to invest up to a total of ₩1.4 trillion (US$1 ...