FDA grants marketing authorization for DNA test assessing predisposition for multiple cancer types.
FDA launches pilot program to accelerate rare disease therapies, improving communication between sponsors and FDA staff. #RareDiseaseTherapies #FDA #ClinicalTrials
FDA authorizes updated mRNA COVID-19 vaccines targeting circulating variants for enhanced protection.
U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test.
FDA releases draft recommendations to modernize clinical trials, incorporating RWE, technology, and increasing diversity.
FDA clears Beta Bionics iLet ACE Pump & iLet Dosing Decision Software for people with type 1 diabetes.
FDA supports DCTs, increasing accessibility, diversity, and efficiency in medical research.
H2O Therapeutics and AmerisourceBergen collaborate to support the commercialization of FDA-cleared Parky app for Parkinson's Disease.
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the...
The FDA has recently approved a cell therapy called Omisirge (omidubicel-onlv) for patients with blood cancers who are undergoing stem cell transplantation. This allogeneic cord blood-based...
