Two SheppardMullin attorneys describe how two recent FDA guidances on pediatric drug development will tighten eligibility for pediatric exclusivity.
FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.
AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...
FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use during transcatheter...
Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.
Federal Register notice: FDA revokes an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injectable emulsion.
CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.
Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patient...
