2025 FDA Approvals: Painkiller Leads Trends, Cancer Prices Climb

Readers picked first-in-class drugs, not cancer drugs

AJMC's ranking of the most-read FDA approvals of 2025 does not include a single oncology drug. A year after the approvals came through, the five that drew the most reader attention were a nonopioid painkiller, a first-ever bronchiectasis treatment, a new drug for lung fibrosis, an expanded label for semaglutide, and a new kind of antibiotic.21 Cancer medicines, meanwhile, made up the largest share of the FDA's novel approvals that year, and their launch prices kept climbing faster than inflation.1331 What people read about and where the regulatory and financial activity happened point in different directions. That split is the most useful way to understand 2025.

The trending five

Vertex's suzetrigine (Journavx) took the top spot. The January approval for moderate-to-severe acute pain created a new drug class, the selective NaV1.8 pain-signal inhibitors, and gave doctors their first new acute-pain drug in more than 20 years.21 Insmed's brensocatib (Brinsupri) ranked second. It is the first approved treatment for non-cystic fibrosis bronchiectasis and the first DPP-1 inhibitor approved for any disease driven by neutrophils.21 Boehringer Ingelheim's nerandomilast (Jascayd) came in third. Approved in October, it was the first new therapy for idiopathic pulmonary fibrosis in over ten years.21 Fourth was an expanded Ozempic label that lets the drug be used to cut cardiovascular risk and slow kidney decline in patients with type 2 diabetes and chronic kidney disease. Fifth was GSK's gepotidacin (Blujepa), the first new oral antibiotic class for uncomplicated urinary tract infections in close to 30 years.21

Other outlets that published year-end lists largely agree on suzetrigine. GoodRx's pharmacists put Journavx, Blujepa and the oral Wegovy pill among the year's most consequential approvals.22 Pharmacy Times put suzetrigine on its own top-five list, though it ranked an at-home brain-stimulation device for depression and a group of sexually transmitted infection treatments higher.28 The lists differ mostly in what they count. Some include devices and label expansions, while others stick to drugs. All of them reward approvals that open a new mechanism or treat a disease that had nothing before.

The FDA's own report supports that focus. The Center for Drug Evaluation and Research (CDER) classified 20 of its 46 novel approvals in 2025, or 43%, as first-in-class.17

The numbers behind the approvals

CDER approved 46 novel drugs in 2025, down from 50 in 2024 and 55 in 2023 but well above the 37 approved in 2022.2614 Including biologics cleared by the Center for Biologics Evaluation and Research, the total was 58.12 The FDA notes that its ten-year average is about 47 approvals a year, so 2025 was a typical year rather than a weak one.17

The agency also leaned heavily on expedited pathways. Seventy-two percent of the novel drugs used at least one expedited program, 24% came through accelerated approval, and 33% had breakthrough therapy designation.17 One tracker found that breakthrough designations have doubled as a share of approvals since 2023, even as the total number of approvals fell.19 CDER met its user-fee review deadlines for 44 of the 46 drugs, and 70% of the novel drugs were approved in the U.S. before anywhere else.17 One analysis noted that the agency did this despite leadership changes, a reorganization, and a 43-day government shutdown in the fall.13

In this context, the number of approvals tells you less than the kind of drugs that got through. Half the novel drugs had orphan designation for rare diseases.17 That matters a great deal for pricing.

Cancer led the count, depending on who's counting

Sources disagree on how many 2025 approvals were cancer drugs, and the reason is how they define the category. CDER-based tallies cited by C&EN and RAPS put oncology at 14 approvals (C&EN's figure combines oncology and hematology).2614 Parexel and a review in a peer-reviewed journal count 16 novel oncology drugs, which works out to about 28% of the year's approvals.151 The larger count includes products that sit on the line between categories, such as the stem-cell transplant conditioning agent treosulfan and mirdametinib for neurofibromatosis type 1.1 Under either count, cancer was the largest therapeutic area.

The kinds of cancer drugs approved were just as telling. Kinase inhibitors made up seven of the 16, many of them aimed at specific molecular subsets of non-small cell lung cancer (NSCLC).1 Within about six months, taletrectinib (ROS1), sunvozertinib (EGFR exon 20), telisotuzumab vedotin (c-Met), and two HER2-targeted drugs, zongertinib and sevabertinib, all reached the market. Most of them came through accelerated approval.27 Seven of the 16 oncology drugs (44%) won accelerated approval, typically based on response rates rather than survival data.15 Telisotuzumab vedotin, for example, was approved on a 35% objective response rate from a phase 2 study.2

Cancer care also changed in ways that don't appear in novel-drug counts. Expanded indications included sotorasib plus panitumumab for KRAS G12C-mutated colorectal cancer and trastuzumab deruxtecan for HER2-low and HER2-ultralow breast cancer.236 Merck's subcutaneous Keytruda Qlex was counted as a novel approval.14 Late in the year the FDA also cleared the first interchangeable biosimilar to pertuzumab, which may be a cheaper option for HER2-positive breast cancer.10

The general public pays little attention to approvals like these because each one serves a narrow, biomarker-defined group of patients. This publication's view is that the lung-cancer cluster was nonetheless the most significant clinical trend of 2025. It also raises the hardest questions about pricing.

What the trending drugs cost

The top two drugs on AJMC's list show two different pricing strategies. Vertex set a wholesale price of $15.50 per 50 mg tablet for Journavx.47 Yale clinicians pointed out that the drug is usually taken twice a day, while hydrocodone-acetaminophen costs $1 to $2 a pill.42 A two-week course costs roughly $420 at list price.44 Medicare covers Journavx inconsistently: it is bundled into inpatient hospital payments, excluded from Part B, and left to individual Part D plans, many of which add prior authorization or put it on a non-preferred tier.49 That price gap is a real obstacle for a drug whose public-health case rests on displacing cheap opioids.

Insmed priced Brinsupri at $88,000 a year, the same for both doses. Analysts called that the high end of what they expected.5655 The company estimated its net price would be 25% to 35% lower after rebates. Insmed has said it expects at least $1 billion in Brinsupri sales in 2026. Its CEO also said the company is holding off on launches in Europe and Japan until the effects of the Trump administration's Most Favored Nation pricing policy are clear. That decision shows how U.S. price policy is now influencing when, and whether, drugs launch in other countries.

Launch prices: a dip in 2025, but still rising over time

Recent coverage of launch prices can look contradictory. A 3 Axis Advisors analysis reported by Reuters found that the median annual list price of drugs approved in 2025 fell to $216,000, from more than $370,000 in 2024.38 Researchers explained that the drop came from the mix of drugs approved, including fewer multimillion-dollar gene therapies, and not from any change in how companies set prices.38 A JAMA study from Harvard researchers found that median launch prices rose from about $39,000 in 2008 to more than $250,000 in 2025, an increase of roughly 16% a year, with no slowdown after the Inflation Reduction Act.36

The two findings measure different things. One is a single year's group of drugs; the other is a trend over nearly two decades. The long-term trend is the better guide. Harvard's Benjamin Rome, who has studied both, called 2025 "an odd year."40

Cancer drugs are where the long-term increase is steepest. A JAMA analysis of 86 oral targeted cancer therapies found that the average monthly launch price rose from $10,954 for drugs first listed in 2012–2014 to $27,891 for drugs first listed in 2023–2025, after adjusting for inflation.31 Bloomberg separately put the median launch price of a new cancer drug at about $25,000 a month and reported that many expensive cancer drugs have not been shown to extend survival.34 Prices have risen even further since: Rasonque, a pancreatic cancer drug launched in 2026, costs about $480,000 a year.36

What 2025 shows

The approvals that trended in 2025 were mostly priced for large markets. Journavx costs a few hundred dollars per course, and Brinsupri's price is high but well short of rare-disease levels. They are also the drugs most often used to argue that the FDA's approval process works. The cancer approvals point to a less comfortable conclusion. The agency is approving many targeted drugs quickly, often on early response data, and each new drug launches at a higher price than the ones before it.

Drugmakers argue that new medicines lower other healthcare costs, and the industry's trade group says comparing rare-disease prices with prices for other drugs is misleading.40 That may be true for a particular drug. But the 2025 approvals did nothing to change the overall pattern: the FDA keeps approving novel drugs at a steady pace, and new-drug prices keep rising.