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...
HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...
Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery...
FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns therapeutic equivalence c...
CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instructions for Portrait ...
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...
Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.
