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Susan Haigney is lead editor of BioPharm International®.
March 07, 2024
FDA has published final guidance documents regarding validation and development of analytical procedures.
March 06, 2024
The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.
March 03, 2024
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
February 28, 2024
The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.
February 27, 2024
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
February 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.