Transmedics panel defies expectations
A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
Narrowed label for Biogen’s Aduhelm lays bare FDA’s fail
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.
Glaxo needs long-acting HIV gamble to pay off
Dolutegravir’s patent expiry will pile on the pressure as Gilead and Merck get on the long-acting bandwagon.
The big approvals still on the cards for 2021
Biogen’s Aduhelm was the big one, but there are plenty of other key regulatory decisions still pending this year.
