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.
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.