Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early endpoint in clinical t...
FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biol...
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...