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March 16, 2024
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
March 11, 2024
The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.
March 08, 2024
The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.
March 07, 2024
The agency has published final guidance documents regarding validation and development of analytical procedures.
March 04, 2024
Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.
February 28, 2024
Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
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 23, 2024
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
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.
AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.