Replies to post #255036 on Biotech Values

[dewophile]

Bears will say the agency is pushing approvals through before gridlock sets in. Bulls will call this a sign of a functioning FDA.

[DewDiligence]

FDA approves Opdivo/Yervoy for 1L-HCC—before PDUFA date:

https://www.businesswire.com/news/home/20250401202312/en/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-plus-Yervoy-ipilimumab-as-a-First-Line-Treatment-for-Unresectable-or-Metastatic-Hepatocellular-Carcinoma

This Opdivo/Yervoy approval, which is entirely separate from the one announced earlier this week in colorectal cancer (#msg-176039474), had a PDUFA date of 4/21/25.

FDA approvals remain timely, at least for BMY.