Not so fast for some accelerated approvals
The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.
Fourth-quarter data for the little guys
Relmada, Albireo and Mirum prepare for important clinical results, as Intercept is set back again.
EHA 2022 preview – some good news at last
Positive data result in positive share price movements – something of a novelty in the current market.
Ash 2021 movers – IGM steals the show, for all the wrong reasons
At a meeting lacking practice-changing studies and featuring many disappointments the downturn in IGM’s fortunes stands out.
Biggest unpartnered assets: Argenx nears crunch time
Amid cautionary tales of other highly valued unpartnered assets, efgartigimod approaches its US date with destiny.
Ash 2021 preview – as competition grows Autolus monetises
Several cell therapy presentations will vie for attention at Ash, though today the spotlight falls on Autolus.
Allogene raises the spectre of a Car-T nightmare
Little is known about yesterday’s clinical hold on Allogene’s entire pipeline, but chromosomal abnormalities hint at a worst-case scenario.
Smaller companies set for third-quarter catalysts
The third quarter will see important data for Travere, Radius and Sio Gene, among other small developers.
