In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.

The company launched Amjevita on the same day it announced fourth quarter 2022 earnings and provided 2023 guidance, upping the high-profile nature of the first-to-market US Humira biosimilar.

Even with top-seller Biktarvy and its preventive therapy, Descovy, protected beyond this decade from generics, Gilead is investing aggressively in long-acting HIV candidates and its oncology pipeline.

The Swedish biotech is stepping up its business development plans ahead of a mid-stage readout in the summer for ACD440, its TRPV1 antagonist for neuropathic pain.