Go or no go? Key FDA decisions for Argenx and Regeneron
Pdufa dates are also set for Sarepta and UCB, and panels will discuss Leqembi and Beyfortus.
Viking’s Voyage is not over yet
A hit on one goal helps, but future Nash data will be more decisive.
Go or no go? Sarepta’s gene therapy faces scrutiny
SRP-9001 heads for its month of regulatory probing, as vaccines from GSK and Pfizer, and Genmab and Abbvie’s bispecific, await FDA approval decisions.
Regulatory developments over the Christmas period
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.
Spotlight - Biotech tries everything it can in Nash
The Nash pipeline is pharmacologically diverse, and some projects look like very long shots.