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.
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.
Meanwhile, there was bad blood between cell therapy players and their investors.
Another five treatment-related deaths, despite a dose regimen change, raise questions about whether odronextamab will be able to compete.
The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.
In oncology settings outside multiple myeloma investors have picked two early winners.