HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...
FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ...
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme elevations were unco...
FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identified in five participa...
FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive ai...
FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathol...
Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.
House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data ge...
