The FDA’s 2023 approvals reflect a broad range of advances, from new drugs to treat oncology and hematology indications to first-in-class treatments for rare diseases like hereditary angioedema and neurofibromatosis type 1. Citeline’s Biomedtracker estimates that the agency will deliver close to 70 approvals and label expansions this year, with oncology remaining the most prominent disease area.

In recent years, the FDA has accelerated the approval process for drugs with potentially life-changing effects. It’s been a major focus of drug industry lobbyists, who have pushed for special programs and pathways to expedite reviews. The Trump administration’s new plan will expand those opportunities, though it also grants FDA officials unprecedented discretion in selecting which companies get the fastest reviews.

That approach has raised concerns among some observers, including Gregg Gonsalves, who was a member of the activist group ACT UP in the 1980s and accused the FDA of holding back HIV cures. “I worry that this is just another way to reward pharma and let them have their cake and eat it too,” he says.

But the FDA’s secrecy may be finally ending. The agency has begun to publish complete responses to applications, which typically specify the reasons for rejecting a medication. This unprecedented transparency could help patients, as long as the FDA is willing to use it wisely. But that will require a rethinking of the bureaucracy’s rigid decision-making.