OR WAIT null SECS
March 16, 2024
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
March 07, 2024
The agency has published final guidance documents regarding validation and development of analytical procedures.
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.
February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
January 31, 2024
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.