Go or no go? Vaccines and neurology up for discussion
FDA panels loom for GSK and Biogen, with approval decisions due for Acadia and Biomarin.
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.
Go or no go? Lecanemab’s destiny approaches
2023 begins with FDA decisions for Eisai’s Alzheimer’s project and Pfizer’s zavegepant, with an adcom for Cidara’s rezafungin.
CTAD 2022 – lecanemab data hold up, with a big but
Keenly awaited results reveal no smoking gun, but lecanemab’s modest activity appears not that different from Aduhelm’s.
Go or no go? Mirati heads to the FDA
TG Therapeutics and Gilead also await a verdict, and Cytokinetics is set for a panel.
AHA 2022 – History repeats for Medtronic
The company’s renal denervation system has failed in a crucial late-stage trial, just as an earlier version did eight years ago.
Abeona takes on Amryt – and more importantly, Krystal
Three new epidermolysis bullosa therapies are approaching the US, and expectations vary wildly.
