FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.
The Italian company’s North American business has seen an increase of 47%.
The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.
The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.
The agency has published final guidance documents regarding validation and development of analytical procedures.
The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.
The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.
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.
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.