Intercept’s woes have continued as a possible new liver toxicity signal was buried in a regulatory filing. What could this mean?
Approval of ALKS 3831 looks likely after Friday’s positive panel vote, but sales might disappoint.
With the EU regulator already reviewing two coronavirus vaccines, could it beat the US FDA to the punch?
Software-enabled medical devices pose unique challenges to regulators, and the US agency is getting serious about meeting them.
The BinaxNow antigen test is fast and acceptably accurate – but above all, cheap.
The liquid biopsy era is finally here.
The latest Covid-19 vaccine award sees Glaxo and Sanofi score a $2.1bn windfall from the US government.
There was a time when President Trump could mention drug pricing controls and move markets. Now, not so much.
Batch testing could allow large numbers of people to be ruled out as having Covid-19, but accuracy concerns remain.