Replimune plans a BLA submission for its RP1 therapy in combination with nivolumab for treating melanoma patients whove failed an anti-PD1 therapy.
Federal Register notice: FDA issues an order debarring Marina Sievert for 10 years from importing or offering for import any drug into the U.S.
Medexus Pharmaceuticals says FDA has accepted for review its Medac licensors resubmitted NDA for treosulfan, indicated for combination use with fludar...
FDA medical reviewer raise some issues about Lillys investigational Alzheimers drug donanemab for advisory committee members to consider.
The Government Accountability Office says stakeholder groups have identified issues with OTC hearing aids that need to be monitored.
Reps. DeGette and Buchson ask for input on steps Congress can take to help develop the next generation of healthcare treatments.
FDA and the Clinical Trials Transformation Initiative announce an 8/6 hybrid public workshop on artificial intelligence in drug and biological product...
University of MissouriKansas City researchers say pediatric orthopedic device innovation lags substantially behind adult device innovation.
